Remove That Gallbladder? Not So Fast

MINIMALLY INVASIVE Personalized medicine might limit the number of unnecessary cholecystectomies.

Some people with gallstone pancreatitis are fine years later without gallbladder removal, according to a study published in the American Journal of Gastroenterology — a finding that makes it fair to question whether the standard treatment of removing the gallbladder within 30 days of gallstone pancreatitis is overly aggressive.

Patients suffering from acute biliary pancreatitis often undergo cholecystectomy within 4 weeks of diagnosis, a timing that is in accordance with accepted clinical guidelines.

Researchers at Johns Hopkins Medicine in Baltimore, Md., reviewed the outcomes of 17,000 cases of acute biliary pancreatitis diagnosed between 2010 and 2013. Of the 78% of patients who had their gallbladders removed within a month of the initial diagnosis, less than 10% required follow-up treatment for pancreatitis. Of the 3,700 patients who did not undergo cholecystectomy within 30 days of diagnosis, about 1,200 ended up having their gallbladders removed within 6 months. However, nearly 2,500 patients who did not have the surgery — because of a lack of resources or surgeon or patient preference — still had not undergone the procedure 4 years later.

More research is needed to determine why some patients who didn't undergo surgery experienced recurrence of acute biliary pancreatitis and some did not, says Susan Hutfless, PhD, an assistant professor of medicine at Johns Hopkins and the principal investigator. She says the study highlights a potential opportunity to adjust current standards of care through the personalization of cholecystectomy timing.

"But for now," she adds, "there is clear evidence that the current guidelines are beneficial to patients and should be followed."

Daniel Cook

In South Carolina, Proof that Surgical Safety Checklist Really Works

CHECKS AND BALANCES A 19-point checklist prompts members of a surgical team to discuss the surgical plan, as well as any risks or concerns, during each of the 3 phases of a surgery.

South Carolina hospitals that implemented the World Health Organization Surgical Safety Checklist saw a 22% reduction in post-surgical deaths, according to a new study — the first to demonstrate that the Surgical Safety Checklist can significantly improve patient safety at large scale.

The 14 South Carolina hospitals that participated in Safe Surgery South Carolina program saw a 21.9% relative reduction in 30-day post-operative patient mortality. Participating hospitals decreased their 30-day post-operative mortality rate from 3.38% in 2010 — prior to implementation — to 2.84% in 2013, according to a study published in Annals of Surgery. In comparison, the other 44 hospitals in South Carolina had a 30-day post-operative mortality rate of 3.5% in 2010 and 3.71% in 2013.

Adopting a safe surgery checklist has proven to reduce deaths in controlled research studies since 2009. But the ability to produce improved outcomes at large scale to this point has remained elusive.

At the heart of Safe Surgery South Carolina program is a 19-point checklist that prompts members of a surgical team to discuss the surgical plan, as well as any risks and concerns, during each of the 3 phases of a surgical procedure: before the induction of anesthesia ("sign in"); before the incision of the skin ("time out"); and before the patient leaves the OR ("sign out"). In each phase, a checklist coordinator confirms that the surgical team has completed the listed tasks before proceeding.

This 5-year project between the South Carolina Hospital Association (SCHA), Ariadne Labs and the Harvard T.H. Chan School of Public Health was designed as a collaborative effort. Together, participating hospitals implemented the program, which was modeled after the World Health Organization Surgical Safety Checklist developed by a team led by Atul Gawande, MD, executive director of Ariadne Labs.

The success of Safe Surgery South Carolina is the latest evidence supporting the effectiveness of the surgical checklist as a tool for improving patient outcomes. A 2009 pilot study showed similar, significant reductions in post-operative complications and mortality rates in ORs that used a safe-surgery checklist.

SCHA President and CEO Thornton Kirby, FACHE, says South Carolina is honored to act as a "learning lab" for the rest of the country. Furthermore, he says the study has validated the beliefs of the stakeholders from when they embarked on the project in 2010: "If you change the OR culture of how you communicate and coordinate your efforts, you can produce better outcomes."

Bill Donahue

Eliminate Pre-op Testing for Cataract Patients, Save $500 Million

BLOOD LOSS Cataract patients who need blood work and other pre-op testing can be identified with a checklist, says Peter Provonost, MD, PhD.

Want to save half a billion dollars a year? Eliminate the requirement that cataract surgery patients be subjected to electrocardiograms, blood tests, imaging studies and other routine pre-operative testing. That, says Peter Provonost, MD, PhD, would result in enormous saving "with no negative effect on patient health."

Writing in the Wall Street Journal, Dr. Provonost, an anesthesiologist and critical-care physician at Johns Hopkins, points out that the risks associated with such testing are rare in cataract surgery. The rare exceptions — those who truly need preoperative workups — can easily be identified with checklists, he says.

Moreover, no such requirement exists for dental procedures, most endoscopies and office-based minor procedures, he points out. But the federal government and accrediting organizations continue to require such testing before every cataract surgery, the most common procedure for Medicare beneficiaries.

Ensuring patient safety is important, says Dr. Provonost, but a more "nuanced approach" based on medical evidence and expertise is called for to reduce compliance burdens and unnecessary expenses related to cataracts and other procedures. CMS, he says, should focus on identifying and revising or removing regulations that hurt clinician productivity, increase costs and burden patients, while providing no clear benefits.

Jim Burger

InstaPoll: Should U.S. Lawmakers Make Surgical Smoke Evacuation Mandatory?

There are no mandatory smoke evacuation regulations in the United States at this time, but California could become the first state to require the evacuation of surgical smoke in health facilities. Tell us your thoughts on mandatory smoke evacuation in this week's InstaPoll.

Only 50% of the 201 respondents to last week's InstaPoll reported that their preference cards are very or extremely accurate. The results:

How accurate are your preference cards?

  • extremely 17%
  • very 33%
  • moderately 43%
  • slightly 6%
  • not at all 1%

Dan O'Connor

News & Notes

  • Isomeric recalls sterile compounded products over FDA concerns Isomeric Pharmacy Solutions, a 503B compounding lab based in Salt Lake City, Utah, has voluntarily recalled all lots of its sterile compounded medications distributed between Oct. 4, 2016, and Feb. 7, 2017. Isomeric hasn't received any reports of adverse events related to this recall, but has taken this action as a precautionary measure in light of FDA concerns regarding "a lack of sterility assurance." Anyone who has received the affected medications should immediately discontinue the use of and quarantine any unused product. Contact Isomeric by phone — (844) 470-2467 — or email to arrange the return of any unused sterile compounded products.
  • Can stem cells rejuvenate knees? There's hope on the horizon for the 30% of Americans with degenerative knee cartilage, according to Adam Anz, MD, an orthopedic surgeon at the Andrews Institute for Orthopaedics & Sports Medicine in Gulf Breeze, Fla. He'll soon launch research aimed at increasing the amount of stem cells surgeons can harvest from bone marrow transplants to regrow damaged cartilage. He hopes the study will lead to a cost-effective treatment for long-suffering patients.
  • In defense of the ACS surgical risk calculator Though not perfect, the American College of Surgeons surgical risk calculator is both accurate and appropriate across many surgical domains, a new study finds. Researchers say reported failures tend to be associated with small sample sizes, homogeneity and/or limited data, and should not be misunderstood to disqualify the calculator as a useful tool.