Time to phase out transrectal biopsies for prostate cancer
Time to phase out transrectal biopsies for prostate cancer
About 2 million American men per year undergo transrectal (TR) biopsies to diagnose prostate cancer and to monitor the disease in men following a treatment strategy known as active surveillance (AS). As many as 2,000 of them a year--five a day--die from the procedure though it's not reported on death certificates.
Evidence has been growing in recent years that men undergoing the transrectal approach encounter risks of death and disability due to infections and bleeding complications associated with the procedure.
At the same time, a novel approach for prostate biopsy, where the biopsy needles are passed through the perineum or tain’t (the skin between the testicles and rectum), can virtually eliminate the septic infections that can cause death or permanent disability and also result in large, avoidable costs for sepsis and also prevent rectal bleeding from lacerations of internal hemorrhoids.
The Transperineal biopsy (TP) approach to prostate biopsy, can be done safely in the office setting, with only local anesthesia, and minimal changes to the urology office workflow. Adopting the transperineal technique requires a modest learning curve, and this can be greatly mitigated by the use of a new disposable needle guide (which costs about $200 per case) but would likely save Medicare, insurers, and patients themselves as much as $750 million dollars per year in hospitalization costs for sepsis.
So, it is moved:
--About 2 million transrectal biopsies per year are performed in the United States to diagnose prostate cancer and to monitor prostate cancer in men on active surveillance protocols. Most are transrectal biopsies with needles being plunged into the germ-infested rectum.
--Of these men, 5-7% develop infections and 1-2% develop potentially life-threatening and disabling sepsis, according to the American Urological Association. Sepsis is an infection that spreads into the bloodstream and can cause a cascade of deadly symptoms.
--An estimated one in 1,000 men undergoing transrectal biopsies will die from sepsis. That comes to 2,000 American men per year. (Dr. T, Johansen, Oslo University Hospital, Norway,
--Hospitalization for sepsis costs between $8,672 and $19,000 per patient for post-biopsy admissions borne by Medicare, other insurers, and patients themselves. (Richard Szabo, MD, the University of California, Irvine https://www.liebertpub.com/doi/abs/10.1089/end.2020.1093
--The total cost for the “transrectal biopsy tax” is between $342 million and $753 million. This money could be saved primarily through the elimination of admissions for post-biopsy sepsis. (Szabo)
-- The microbes in the rectum have become increasingly resistant to antibiotics, making it more difficult to prevent and treat infections. The medical field continues to practice poor stewardship of antibiotics, advocating for the use of stronger antibiotics in the prophylactic setting, thereby increasing risks from these infections.
-- TP biopsies practically eliminate the use of prophylactic antibiotics for the procedure.
--Leading urologists from around the world have called for the TR prostate biopsy to be abandoned and suggested a plan (named “TRexit 2020”) to phase it out by the end of 2022. (Jeremy Grummet et al, Prostate Cancer and Prostatic Diseases, 13 January 2020. https://www.nature.com/articles/s41391-020-0204-8
--Research has shown that cancer detection is improved with the TP biopsy because the transperineal route facilitates access to the anterior region, a region of the prostate that harbors 25% of cancer, yet is often not easily reachable with the TR approach.
--The European Association of Urology in January 2021 issued a position paper that states: “Available evidence highlights that it is time for the urological community to switch from a transrectal to a transperineal [prostate biopsy] approach despite any possible logistical challenges.” https://www.sciencedirect.com/science/article/pii/S0302283820308083
--The American Urological Association’s 2017 “White Paper on the Prevention and Treatment of the More Common Complications Related to Prostate Biopsy” mentions TP biopsies as an option along with TR biopsies but they repeat the outdated notion that TP biopsies require general anesthesia and they state it is unclear whether the risk of overall complications is significantly different than that of TR biopsy, which is patently untrue as sepsis and rectal bleeding are virtually eliminated with the TP approach.
(Liss MA, Ehdaie B, Loeb S, Meng MV, Raman JD, Spears V, Stroup SP. An Update of the American Urological Association White Paper on the Prevention and Treatment of the More Common Complications Related to Prostate Biopsy. J Urol. 2017 Aug;198(2):329-334. doi: 10.1016/j.juro.2017.01.103. Epub 2017 Mar 29. PMID: 28363690.https://www.auajournals.org/doi/10.1016/j.juro.2017.01.103
--Thee 2018 AUA guideline on Early Detection of Prostate Cancer contains a single mention of TP, referring to older technology.
Therefore, be it resolved that:
--The American Urological Association update its white paper on Optimal Techniques of Prostate Biopsy and Specimen Handling and The Prevention and Treatment of the More Common Complications Related to Prostate Biopsy Update as well as the guideline on Early Detection of Prostate Cancer and make transperineal biopsies the first-line choice for prostate biopsies. AUA needs to update its guidelines on coding and reimbursement and promote them through the appropriate channels so that urologists can be paid properly for switching to transperineal biopsies. (Meanwhile, with the shortage of urologists trained in modern TP skills, patients will be forced to make difficult decisions on whether to proceed with TR procedures or to postpone their biopsies.)
--Congress, the Centers for Medicare & Medicaid Services and insurers should incentivize urologists to perform TP biopsies instead of TR biopsies by covering the additional costs to the urologist of the increased procedural time and the disposable needle guide required for TP biopsies. Likewise, private insurers should take similar steps.
--Patients and their advocates need to urge urologists to adopt the new approach in the name of patient safety and saving unnecessary costs to the medical system for sepsis, antibiotic use, and rectal bleeding.
Patients should rise up and demand that their health and safety be protected. Urologists will resist changing what they do until they encounter patient demand for change.