News in Brief

FROM THE EDITOR

COVID-19 Research Effort Unprecedented

The COVID-19 pandemic, the most devastating health crisis in more than a century, will be entering its third year in March. As of January 14, some 317 million COVID-19 cases and 5.5 million related deaths have occurred worldwide, according to the Johns Hopkins Coronavirus Research Center. The United States has tallied approximately 62.5 million COVID19 cases and 840,000 related deaths, according to the Centers for Disease Control and Prevention. The rapid spread of SARS-CoV-2, the novel coronavirus that causes COVID-19, and the resulting human toll and societal and economic disruption have led to an unprecedented worldwide marshalling of research efforts. SARS-CoV-2 has become perhaps the most studied virus in history. (See COVID-19 articles on pages 19 and 20.)

This is reflected in PubMed, the database maintained by the National Institutes of Health. A search of that database on January 14 using the term “COVID-19” retrieved 217,349 citations related to the disease. That’s in just 2 years. By comparison, a search for “influenza” turned up 145,583 citations in the entire database. HIV had more entries (390,846), but that’s for research published during the approximately 4 decades since the virus was first recognized.

The COVID-19 research effort to date has identified risk factors for SARS-CoV-2 infection, characterized the spectrum of clinical manifestations of infection, and zeroed in on which treatments are effective and those that are not. Such knowledge could lead to improved infection control measures and therapeutics for SARS-CoV-2 and perhaps better prepare us for whatever epidemic or pandemic comes next.

The second year of the pandemic comes to an end with the emergence of a SARS-CoV-2 variant called Omicron. This variant is extremely transmissible, with experts saying they have never seen such a communicable virus. But it appears to cause milder disease than other variants. It remains unclear what the appearance of this less-virulent form of the virus means for the trajectory the pandemic.

Regardless, like pandemics before it, this one will end eventually. The massive effort underway to vaccinate people against the virus has slowed its spread, but challenges remain in persuading millions of reluctant individuals to get their shots. SARS-CoV-2 could become endemic like seasonal influenza, with people learning to live with it, experts say. Meanwhile, researchers around the globe continue to probe COVID-19 from every scientific angle, and probably will do so for years to come.

Jody A. Charnow

Editor

Interested in writing an editorial for Renal & Urology News? Please email Jody A. Charnow, Editor, at jody.charnow@haymarketmedia.com

EDITORIAL ADVISORY BOARD

Medical Director, Urology

Robert G. Uzzo, MD, MBA, 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 Urologists

Christopher S. Cooper, MD

Director, Pediatric Urology Children’s Hospital of Iowa Iowa City

R. John Honey, MD

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

Stanton Honig, MD

Department of Urology Yale University School of Medicine New Haven, CT

J. Stephen Jones, MD

Chief Executive Officer Inova Health System Falls Church, VA Professor and Horvitz/Miller Distinguished Chair in Urologic Oncology (ret.) Cleveland Clinic Lerner College of Medicine Cleveland

Jaime Landman, MD

Professor of Urology and Radiology Chairman, Department of Urology UC Irvine School of Medicine Orange, CA

James M. McKiernan, MD

John K. Lattimer Professor of Urology Chair, Department of Urology Director, Urologic Oncology Columbia University College of Physicians and Surgeons New York

Kenneth Pace, MD, MSc

Assistant Professor, Division of Urology St. Michael’s Hospital University of Toronto Vancouver, Canada Medical Director, Nephrology

Kamyar Kalantar-Zadeh, MD, PhD, MPH

Professor & Chief, Division of Nephrology, Hypertension & Kidney Transplantation UC Irvine School of Medicine Orange, CA

Nephrologists

Anthony J. Bleyer, MD, MS

Professor of Internal Medicine/Nephrology Wake Forest University School of Medicine Winston-Salem, NC

David S. Goldfarb, MD

Professor, Department of Medicine Clinical Chief New York University Langone Medical Center Chief of Nephrology NY Harbor VA Medical Center

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

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. Denver

Rulan Parekh, MD, MS

Associate Professor of Pediatrics and Medicine University of Toronto

Robert Provenzano, MD

Associate Professor of Medicine Wayne State University School of Medicine Detroit Vice President of Medical Affairs, DaVita Healthcare Denver

Renal & Urology News Staff

Editor Jody A. Charnow Web editor Natasha Persaud Production editor Kim Daigneau Group creative director Jennifer Dvoretz Production manager Brian Wask Vice president, sales operations and production Louise Morrin Boyle National accounts manager William Canning Editorial director, Haymarket Oncology Lauren Burke Vice president, content, medical communications Kathleen Walsh Tulley Chief commercial officer James Burke, RPh President, medical communications Michael Graziani Chairman & CEO, Haymarket Media Inc. Lee Maniscalco

News in Brief

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

Short Takes

Drug for Post-Transplant CMV Infection Approved

Maribavir (Livtencity, Takeda Pharmaceuticals) received FDA approval as the first drug to treat adults and pediatric patients aged 12 years or older with post-transplant cytomegalovirus (CMV) infection that does not respond to available antiviral treatment for CMV. The drug prevents activity of human cytomegalovirus enzyme pUL97, thereby blocking virus replication.

The drug received Breakthrough Therapy and Priority Review designations for this indication. Approval was based on data from the phase 3 openlabel SOLSTICE trial.

5ARI Use Linked to Lower SARS-CoV-2 Infection Risk

Use of 5-alpha-reductase inhibitors (5ARIs) in men without prostate cancer was associated with a significantly lower risk for community acquired SARS-CoV-2 infection in a study of 60,474 men tested for the novel coronavirus that causes COVID-19.

The absolute risk for infection was 42.3% among users of 5ARIs compared with 47.2% among nonusers, Madison Lyon, MD, of Glickman Urological and Kidney Institute at Cleveland Clinic in Ohio, reported in the Journal of Urology. Users of 5ARIs had significant 19% lower odds of infection compared with nonusers. In addition, 5ARI use was not associated with disease severity, they noted.

Kidney Function Decline Predicts Death Risk in LN

Kidney function decline is an independent predictor of mortality among patients with lupus nephritis (LN), according to study published in Lupus.

Seung-Ki Kwok, MD, of Seoul St Mary’s Hospital, The Catholic University of Korea, and colleagues examined data from 401 Korean patients diagnosed with LN from 1985 to 2019, including 53 who died during 131 months of follow-up.

On multivariate analysis, only final kidney function in the range of chronic kidney disease stage 4 remained an independent predictor of mortality. It was significantly associated with a 5.8-fold increased risk for early death, Dr Kwok’s team reported.

The top causes of death in the LN cohort were infection, lupus flare, cardiovascular disease, and malignancy.

Home Dialysis On the Rise

The proportion of incident dialysis patients performing home dialysis (shown in green) and patients performing home dialysis at 1 year after dialysis initiation (shown in blue) increased in the United States from 2009 to 2019.

20

15

10

5

6.8% 12.6%

10.5% 18.2%

0

Likelihood of AF Therapy Linked to CKD Severity

Chronic kidney disease (CKD) in patients with newly diagnosed atrial fibrillation (AF) is significantly associated with a lower likelihood of receiving treatment for AF, and that likelihood decreases as CKD severity increases, according to investigators.

In a study that included 115,564 patients with newly diagnosed AF receiving care in 2 large integrated health care delivery systems, those with an estimated glomerular filtration rate (eGFR, in mL/min/1.73 m2) of 30-44, 15-29, and less than 15 had a significant 9%, 22%, and 36% decreased likelihood of receiving any AF therapy, respectively, in adjusted analyses compared with those who had an eGFR greater than 60, Nisha Bansal, MD, of the Kidney Research Institute at the University of Washington in Seattle, and colleagues reported in the Journal of the American Society of Nephrology. The investigators defined CKD as an eGFR less than 60. Of the study cohort, 34% had CKD at baseline.

Larger RCC Tumors Predict Worse Post-CN Survival

Larger tumor size is an independent risk factor for poor survival after cytoreductive nephrectomy (CN) for renal cell carcinoma (RCC), investigators reported at the 22nd annual meeting of the Society of Urologic Oncology

Among 360 patients (28% female; mean age 61 years) within the 2005-2019 International Marker Consortium for Renal Cancer (INMARC) who received CN and systemic therapy, primary clinical tumor size was 7 cm or greater in 249 patients (69.2%). During follow-up, 218 patients died (61%), including 50 (13.9%) from RCC.

In multivariable analyses, clinical tumor size of 7 cm or greater was significantly associated with 2.6- and 1.5-fold increased risks for cancer-specific mortality and allcause mortality, respectively, Ryan Isaac Nasseri, MD, of the University of California, San Diego, reported in a poster presentation. Hypertension was significantly associated with a 3.7-fold increased risk for cancer-specific mortality.

Frailty May Affect Dialysis Vascular Access Maturation

Greater frailty among patients receiving dialysis is associated with longer times to vascular access functional use, according to study findings published in the American Journal of Kidney Diseases.

The finding is from a study of 41,471 patients, of whom 33,212 underwent fistula creation and 8259 who had graft placement. The investigators ascertained frailty using the claims-based frailty indicator (CFI). Higher scores on the CFI indicate greater frailty. Among patients receiving a fistula, 59% and 72.7% of those in the lowest frailty quartile were using their fistula within 6 and 12 months of creation, respectively, compared with 47.2% and 59.3% of those in the highest frailty quartile, Karen Woo, MD, PhD, of the David Geffen School of Medicine at UCLA, and colleagues reported. In the graft placement group, 67.5% and 71.6% were using their graft within 6 and 12 months of creation, respectively, compared with 66.3% and 69.3% of those in the highest frailty quartile.

Skipping pre-RP biopsy

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PET score of 4 or higher on a 5-point Likert scale and maximum standardized uptake value of 4 or higher.

The investigators acknowledged that their study is limited by the retrospective design and small sample size.

“In this small and very carefully selected group of patients, prostate MRI and PSMA-PET imaging were successful in identifying prostate cancer in all patients,” commented Michael Leapman, MD, assistant professor of urology at the Yale School of Medicine in New Haven, Connecticut, who was not involved with the study. “This work is intriguing because it may suggest the possibility of a diagnostic pathway that avoids prostate biopsy, an invasive procedure that is uncomfortable, costly, and does exposure patients to potential risks.”

Dr Leapman, who is clinical program leader of the Prostate & Urologic Cancers Program at the Yale Cancer Center, said he interprets the findings with caution “as the consequences of exposing even 1 patient without cancer to prostatectomy is substantial, regardless of how they are counseled. Moreover, widespread use of PSMA-PET and prostate MRI raises questions about long-term cost effectiveness and sustainability.”

“While this is an interesting study, and all men were ultimately found to have treatable cancer, the results should be taken with caution given the variability of MRI reading and the concern for false positives,” observed Sanoj Punnen, MD, MAS, associate professor and vice chair of research in the department of urology at the Miller School of Medicine, University of Miami in Florida. “Furthermore, the biopsy provides more information about the true grade and extent of tumor within the prostate, and without this we could underestimate or overestimate the burden of cancer, which could lead to misguided management.” ■

Ablation for RCC Preserves Kidney Function in CKD

THERMAL ABLATION for localized renal cell carcinoma (RCC) preserves kidney function in patients with chronic kidney disease (CKD), according to data presented at the 22nd annual meeting of the Society of Urologic Oncology.

Arighno Das, MD, of the University of Wisconsin in Madison, and colleagues studied 434 patients who underwent a total of 520 thermal ablations (either cryoablation or microwave ablation) for localized RCC (average 1.3 per patient). The patients had a median tumor size of 2.7 cm.

Among patients with CKD stage 3 or higher, the average estimated glomerular filtration rate (eGFR) remained stable during the 12 months following ablation. The average baseline eGFR was 42.6 mL/min/1.73 m2. At 6 and 12 months, the average eGFR was 41.2 and 42.2 mL/min/1.73 m2, respectively.

Patients with CKD stage 3a or higher had a significantly worse 5-year recurrence-free survival rate compared with those who had CKD stage 1 or 2 (73.3% vs 87.5%), but 5-year metastasis-free survival rates did not differ significantly (87.3% vs 91.4%), according to the investigators.

Of the 434 patients, 54 (10.4%) had a solitary kidney and 50 (9.6%) had a prior partial or radical nephrectomy. Patients had a median age of 67 years. ■

PCSM among blacks

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“These findings may have implications for future prostate cancer screening and treatment guidelines.”

Dr Stern and colleaegues noted that Black men are purported to have an increased risk for early and aggressive PCa, which has resulted in recommendations for earlier screening as well as evidence of distinctive treatment patterns. These recommendations, however, lack support by high-quality data, “rendering the validity of these conclusions uncertain.”

The investigators said their findings are consistent with recent pooled analyses of administrative data sets in which adjusting for non-biological differences, including socioeconomic status and health care access, almost eliminated the increased PCSM risk observed among Black men in the United States.

“Data from the Canadian health care system are well suited for studying the association of race and ethnicity and prostate cancer mortality, owing to Canada’s diverse population and universal health care model.”

Similar Findings in the US A recent study of men with PCa in the United States showed no significant difference in PCSM between Black men and White men in an equal-access health care system. The study, led by Brent S. Rose, MD, of the University of California San Diego, compared PCSM between Black and White men using data from the Surveillance, Epidemiology and End Results (SEER) national registry and the Veterans Health Administration (VHA), which provides veterans with equal-access to health care. The study included 311,691 men in the SEER database and 90,749 in the VHA system.

The median follow-up was 5.3 years in SEER and 4.7 years in the VHA. In the SEER group, Black men had significant 32% increased odds for PCSM in adjusted analyses compared with White men, Dr Rose and colleagues reported in the Journal of the National Cancer Institute. In the VHA cohort, however, the investigators found no significant increase in risk. In the SEER group, Black men had 23% increased odds of presenting with metastatic disease compared with white men, whereas in

the VHA group, the races did not differ significantly in the odds of presenting with metastatic disease, according to the researchers.

After adjusting for extent of disease, PSA level, and Gleason score, Dr Rose’s team found no association between race and PCSM in the SEER cohort. Radiotherapy Outcomes A meta-analysis of 7 randomized trials that included a total of 8814 men who received radiotherapy for PCa showed that Black patients have a lower risk for PCSM, biochemical recurrence (BCR), and distant metastases (DM), compared with White patients despite having more aggressive disease.

After adjusting for multiple variables, Black men had a significant 32% decreased risk for PCSM, 21% decreased risk for BCR, and 31% decreased risk for DM compared with White men even though the Black men were more likely to have high-risk disease features, a team led by Amar U. Kishan, MD, of the department of radiation oncology at the University of California, Los Angeles, reported in JAMA Network Open. They found no significant difference in allcause mortality.

The findings suggest that “other determinants of outcome, such as access to care, are important factors of achieving racial equity,” the authors concluded. ■

Recent data may have implications for screening and treatment guidelines.

Higher stone rate

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increase in stone incidence over recent years, and this trend continues, there is the potential need for substantially increased resource utilization. This would mean an increase in the number of emergency department visits, urologic consults, and the need for interventions such as lithotripsy or placement of stents.”

Further, this study underscores the critical need to learn what is driving these trends, as well as the importance of dietary and pharmacologic efforts to preventing stone recurrence, according to the investigators.

In multivariate Poisson regression analyses, hypertension and high cholesterol were significantly associated with 79% and 24% increased risks of passing a symptomatic kidney stone in the past 12 months, respectively. Compared with White adults, Hispanic, Black, and Asian adults had significant 44%, 68%, and 41% lower risks of passing a kidney stone within the past 12 months, respectively. According to the investigators, historical risk factors for stone prevalence may play less of a role in stone incidence. The risk of ever having a kidney stone significantly increased 1.4- to more than 2-fold with age categories older than 20-29 years. Compared with White adults, Hispanic, Black, and Asian adults had significant 24%, 48%, and 49% lower risks for stone history, respectively. Adults in the overweight and obese categories of body mass index (BMI, 25-29.9 and 30 kg/m2 or higher, respectively) had a significant 26% and 44% increased risk for ever having a stone compared with those who had a BMI of 18.5-24.9 kg/m2 . Women had a significant 17% decreased risk for a history of stones compared with men. ■

Urology’s ‘New Normal’ Requires Adaptability

BY JOHN SCHIESZER THE COVID-19 pandemic has dramatically changed how patients are managed. Telehealth platforms are rapidly evolving to allow for sharing of diagnostic imaging and interactive education about disease process and treatment options, according to a panel of experts who spoke at a session called “Re-imagining Our Independent Urology Practices: What’s the New Normal?” at the Large Urology Group Practice Association (LUGPA) 2021 annual meeting.

“Not all follow-up care needs to be done in person. Telepathology has enormous potential for remote testing of urinary and even finger stick blood samples, which can be sent to our labs via commercial parcel companies,” said panelist Thomas Rechtschaffen MD, a urologist with Advanced Urology Centers of New York, a division of Integrated Medical Professionals PLLC, New York, New York.

He added, “I have been advocating in Washington DC on behalf of the AUA [American Urological Association] for deregulation of telehealth legislation to allow for its expansion and broader access. The regulatory waivers implemented at the start of the pandemic were the proverbial crack in the door we’ve been asking for and has allowed Medicare to reimburse for telehealth services.”

In addition, clinicians should examine all the options for home testing to diagnose patients, Dr Rechtschaffen said. There are steps urologists can take to reduce the likelihood of emergency department visits or inpatient post-operative stays. Currently, many patients are still fearful of going to the hospital 3during infectious disease outbreaks.

The urology community has now seen what’s possible because of the pandemic. The new tools and modalities now being adopted, however, need to ensure that they benefit both physicians and patients, Dr Rechtschaffen said. “Challenge your notions about delivery of care and consider all the ways remote care can improve your career satisfaction, your employees’ productivity, your patients’ experience, and the efficiencies of your practices’ functionality,” he said.

“Adaptability, flexibility, and standardization within a practice are more important than ever,” said panelist Kim Ramsey, chief operating officer for Urology of Virginia. “It is an opportune time to change the ‘this is how we’ve always done it mentality.’”

Another panelist, urologist Neal Patel, MD, Director of Robotic Surgery at the Advanced Urology Institute of Georgia in Atlanta, said for him “the new normal” of urology means further migration of more complex procedures like robotics and laparoscopy to the outpatient surgical setting, making hospitals true tertiary care centers; responding to nationwide staffing shortages with automation of both front and back office positions using robotic process automation (RPA) and new technology; and adopting collaborative platforms to allow instantaneous cross practice and cross position communication.

COVID-19 has forced physicians to reconsider how they provide care.

75K 25 25 25 50 50 25 75 75 75 C+M C+Y M+Y 75 50 25 75 50 25

50K 75 50 25 75 50 25 300% 80K, 80C, 70M, 70Y

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25K

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GATF/SWOP Digital Proofing Bar

99.5 0.5 63Y 75C, 63M,

39Y 50C, 39M,

16Y 25C, 16M,

to reduce the risk of CV death plus hospitalization for heart failure

STRONG EFFICACY DATA

Proven 25% RRR (5.3% ARR) in CV death and hHF along with standard of care (HR=0.75, 95% CI 0.65-0.86)†

CONSISTENT SAFETY PROFILE

Across multiple trials and indications

SIMPLE DOSING

Single, once-daily oral 10-mg dose with no titration

“Some examples include our outpatient patient urologic robotic program which we established two years ago as the nation’s first non-hospital affiliated true outpatient program in a standalone ASC [ambulatory surgery center]. COVID enabled changes allowed this program to take off which aligned payor, patients and providers,” Dr Patel said.

RPA has allowed his team to develop a reliable automated workforce that allows the practice to have software working 24/7 all year round, mimicking human tasks in the EMR, practice administration, billing, medical records, and insurance portals. “This allows us to be less reliant on workforce staffing and talent acquisition costs and decrease practice overhead,” Dr Patel said. His office experienced challenges in both indirect clinical and non-clinical staffing as a result of the pandemic, especially in the arena of positions that have a large amount of repetitive and mundane tasks. “COVID has created opportunities more than anything else,” Dr Patel said. “I’m a big believer that quickly and sometimes drastically adapting to major events like COVID results in interesting news processes and innovative technology adoptions.” This new environment resulted in many providers looking at alternatives ways to run their business in the shortterm, but Dr Patel said it also opened urologists’ eyes to the fact that these same changes could protect and optimize their practice long-term. “What worked before will not work in the future,” Dr Patel said. “Reimbursement for services will stay the same or decline while overhead continues to rise. We need to increase our reliance on automation and less on staffing.” ■

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