DiversityNursing Blog

JOE PALCA

www.npr.org 

A promising technique for making brain tumors glow so they'll be easier for surgeons to remove is now being tested in cancer patients.

Eighteen months ago, Shots first told readers about tumor paint, an experimental substance derived from scorpion venom. Inject tumor paint into a patient's vein, and it will actually cross the blood-brain barrier and find its way to a brain tumor. Shine near-infrared light on a tumor coated with tumor paint, and the tumor will glow.

The main architect of the tumor paint idea is a pediatric oncologist named Dr. Jim Olson. As a physician who treats kids with brain cancer, Olson knows that removing a tumor is tricky.

"The surgeons right now use their eyes and their fingers and their thumbs to distinguish cancer from normal brain," says Olson. But poking around in someone's brain with only those tools, it's inevitable surgeons will sometimes miss bits of tumor or, just as bad, damage healthy brain cells.

So Olson and his colleagues at the Fred Hutchinson Cancer Center in Seattle came up with tumor paint. They handed off commercial development of the compound to Blaze Bioscience.

After initial studies in dogs showed promise, the company won approval to try tumor paint on human subjects. Those trials are taking place at the Cedars Sinai Medical Center in Los Angeles.

Dr. Chirag Patil is one of those surgeons. He says it's remarkable that you can inject tumor paint into a vein in a patient's arm, have it go to the brain and attach to a tumor, and only a tumor. "That's a concept that neurosurgeons have probably been dreaming about for 50 years," he says.

Patil says they've now used tumor paint on a about a half dozen patients with brain tumors. They use a special camera to see if the tumor is glowing.

"The first case we did was a deep tumor," says Patil. "So with the camera, we couldn't really shine it into this deep small cavity. But when we took that first piece out and we put it on the table. And the question was, 'Does it glow?' And when we saw that it glows, it was just one of those moments ...'Wow, this works.' "

In this first study of tumor paint in humans, the goal is just to prove that it's reaching the tumor. Future studies will see if it actually helps surgeons remove tumors and, even more importantly, if it results in a better outcome for the patient.

That won't be quick or easy. Just getting to this point has been a long slog, and there are bound to be hurdles ahead.

And even if tumor paint does exactly what it's designed to do, Dr. Keith Black, who directs neurosurgery at Cedars-Sinai, says it probably isn't the long-term solution to brain cancer. "Because surgery is still a very crude technique," he says.

Even in the best of circumstances, Black says, surgery is traumatic for the patients, and tracking down every last cell of a tumor is probably impossible. Plus, it's inevitable that some healthy brain tissue will be damaged in removing the tumor.

"Ultimately, we want to eliminate the need to do surgery," says Black. A start in that direction will be to use a compound like tumor paint to deliver not just a dye, but an anti-cancer drug directly to a tumor. That's a goal several research groups, including Jim Olson's, are working on.

  PAULA SPAN

What she wanted, the patient told the geriatricians evaluating her, was to be able to return to her condominium in Boston. She had long lived there on her own, lifting weights to keep fit and doing her own grocery shopping, until a heart condition worsened and she could barely manage the stairs.

So at 94, she consented to valve replacement surgery at a Boston medical center. “She never wanted to go to a nursing home,” said Dr. Perla Macip, one of the patient’s geriatricians. “That was her worst fear.”

Dr. Macip presented the case on Saturday to a meeting of the American Academy of Hospice and Palliative Medicine. The presentation’s dispiriting title: “The 30-Day Mortality Rule in Surgery: Does This Number Prolong Unnecessary Suffering in Vulnerable Elderly Patients?”

Like Dr. Macip, a growing number of physicians and researchers have grown critical of 30-day mortality as a measure of surgical success. That seemingly innocuous metric, they argue, may actually undermine appropriate care, especially for older adults.

The experience of Dr. Macip’s patient — whom she calls Ms. S. — shows why.

Ms. S. sustained cardiopulmonary arrest during the operation and needed resuscitation. A series of complications followed: irregular heartbeat, fluid in her lungs, kidney damage, pneumonia. She had a stroke and moved in and out of the intensive care unit, off and on a ventilator.

After two weeks, “she was depressed and stopped eating,” Dr. Macip said. The geriatricians recommended a “goals of care” discussion to clarify whether Ms. S., who remained mentally clear, wanted to continue such aggressive treatment.

But “the surgeons were optimistic that she would recover” and declined, Dr. Macip said.

So a discussion of palliative care options was deferred until Day 30 after her operation, by which time Ms. S. had developed sepsis and multiple-organ failure. She died on Day 31, after life support was discontinued.

The key number here, surgeons and other medical professionals will recognize, is 30.

Thirty-day mortality serves as a traditional yardstick for surgical quality. Several states, including Massachusetts, require public reporting of 30-day mortality after cardiac procedures. Medicare has also begun to use certain risk-adjusted 30-day mortality measures, like deaths after pneumonia and heart attacks, to penalize hospitals with poor performance and reward those with better outcomes.

However laudable the intent, reliance on 30-day mortality as a surgical report card has also generated growing controversy. Some experts believe pressures for superior 30-day statistics can cause unacknowledged harm, discouraging surgery for patients who could benefit and sentencing others to long stays in I.C.U.s and nursing homes.

“Thirty days is a game-able number,” said Dr. Gretchen Schwarze, a vascular surgeon at the University of Wisconsin-Madison and co-author of an editorial on the metric in JAMA Surgery. Last fall, she led a session about the ethics of 30-day mortality reporting at an American College of Surgeons conference.

“Surgeons in the audience stood up and said, ‘I can’t operate on some people because it’s going to hurt our 30-day mortality statistics,’” she recalled. The debate is particularly urgent for older adults, who are more likely to undergo surgery and to have complications.

Those questioning the 30-day metric point to potential dilemmas at both ends of the surgical spectrum. Surgeons may decline to operate on high-risk patients, even those who understand and accept the trade-offs, because of fears (conscious or not) that deaths could hurt their 30-day results.

At a hospital in Pennsylvania, for instance, a cardiothoracic surgeon declined to operate on a man who urgently needed a mitral valve replacement. He wasn’t elderly, at 53, but he was an alcoholic whose liver damage increased his risk of dying.

Dr. Douglas White, the director of ethics and decision-making in critical illness at the University of Pittsburgh School of Medicine, was asked to consult. According to Dr. White, the surgeon explained that “we have been told that our publicly reported numbers are bad, and we have to take fewer high-risk patients.”

Other surgeons at the hospital, under similar pressure, also refused. A helicopter flew the patient to another hospital for surgery.

An outlier case? A study in JAMA in 2012 compared three states that require public reporting of coronary stenting results to seven nearby states that didn’t report. Older-adult patients having acute heart attacks had substantially lower rates of the stenting in the reporting states. Doctors’ concerns about disclosure of poor outcomes might have led them to perform fewer procedures, the authors speculated; they might also have weeded out poorer candidates for surgery.

Perhaps as important for older people, when things go wrong, surgical teams concerned about their 30-day metrics may delay important conversations about palliative care or hospice, or even override advance directives.

“There are no good published studies on this, but it’s something we see,” Dr. White said. “Surgeons are reluctant to withdraw life support before 30 days, and less reluctant after 30 days.”

That may have been what happened to Ms. S. Or perhaps her aggressive treatment resulted from a surgical ethos that has little to do with mortality reports.

“We want to cure patients and help them live, and we consider it a failure if they don’t,” said Dr. Anne Mosenthal, who heads the American College of Surgeons committee on surgical palliative care.

With surgeons already prone to optimism and disinclined to withdraw life support, the effect of reporting failures, if there is one, is subtle. Surgeons tell themselves, “Maybe if we wait a little longer, he’ll improve; there’s always a chance,” Dr. Mosenthal said.

But many older patients, and their families, have different ideas about what makes life worth sustaining and might welcome a frank discussion before a month passes.

“The 30-day mortality statistic creates a conflict of interests,” said Dr. Lisa Lehmann, an associate professor of medical ethics at Harvard Medical School. “It can lead to the violation of a physician’s duty to put patients’ interests first.”

Leaders at the nonprofit National Quality Forum, which just endorsed 30-day mortality as a measure for coronary bypass surgery, find such fears overblown. The forum evaluates quality measures for Medicare and other insurers, and went ahead with its endorsement despite some physicians’ objections.

“There is some concern,” said Dr. Helen Burstin, the chief scientific officer of the forum, but “certainly no evidence” that the metric is unduly influencing patient care.

“Is it better not to measure and compare, just because we can’t get it perfect?” added Dr. Lee Fleisher, a co-chairman of the forum’s surgery standing committee.

But critics think other quality measures might serve better. Perhaps the benchmark should be 60- or 90-day mortality. Perhaps patients having palliative surgery to relieve symptoms should be tracked separately, because comfort is their goal, not survival.

Maybe quality should include days spent in an I.C.U. or on a ventilator, Dr. Schwarze said.

“Medicine isn’t just about keeping people alive,” she said. “Some of it is about relieving suffering. Some of it is about helping people die.”

Source: www.nytimes.com

By Dr. Chethan Sathya

Inside the operating room, video cameras track every movement. Outside, a small computer-like device analyzes the recordings, identifying when mistakes are made and providing instant feedback to surgeons as they operate.

This is the dream of the surgical "black box." Operations could become flawless. Post-operative complications could be significantly reduced. Surgeons could review the footage to improve their technique and prep for the next big case.

Such a device isn't far from reality.

Researchers in Canada are working on a surgical tracking box -- like the ones placed in airplanes -- that records surgeons' movements and identifies errors during an operation.

By pinpointing mistakes and telling surgeons when they're veering "off course," a black box could prevent future slip-ups, says Dr. Teodor Grantcharov, a minimally invasive surgeon at St. Michael's Hospital in Toronto. Unlike the so-called black boxes in aviation, which are used after disasters occur, the surgical black box Grantcharov is creating will be used proactively to prevent major patient complications.

A number of hospitals have already expressed interest in using the device, Grantcharov says.

But the litigious medical environment may make its implementation problematic. If the recordings were used in court, they could open the floodgates to a new wave of malpractice concerns, which would be counterproductive to surgeons and patients, Grantcharov says.

"We have to ensure the black box is used as an educational tool to help surgeons evaluate their performance and improve," he says.

A work in progress

Grantcharov's black box is a multifaceted system. In addition to the actual box, it includes operating room microphones and cameras that record the surgery, the surgeon's movements and details about team dynamics.

It will allow surgeons to hone in on exactly what went wrong and why.

The black box will eventually assess everything from how surgeons stitch to how delicately they handle organs and communicate with nurses during high-stress situations. Error-analysis software within the black box will help surgeons identify when they are "deviating" from the norm or using techniques linked to higher rates of complications.

So far, Grantcharov's black box has been tested on about 40 patients undergoing laparoscopic weight-loss surgery.

"At this initial stage, we are analyzing surgeries to determine how many errors occur and which ones actually lead to bad results for patients," Grantcharov says. Not every error will result in a patient complication.

Grantcharov's initial research has shown that surgeons recognize few of their mistakes, and, on average, make about 20 errors per surgery -- regardless of experience level. Once Grantcharov's team determines which errors affect patient safety, it hopes to be able to provide this information to surgeons in real time. The team has also developed software that can synthesize the recorded data into user-friendly and interpretable information for surgeons.

The concept of using a black box in surgery isn't new. But until now, the technology never made it out of the laboratory because it lacked comprehensiveness, Grantcharov says. Earlier surgical black boxes didn't record all the important elements of the operating room, he says, leaving pieces of the puzzle missing.

"To truly understand what causes an error, you need to know all the factors that may come into play."

Recording mistakes

Grantcharov was inspired to develop the surgical black box after years of witnessing how patient complications affected surgeons.

"The feeling of not knowing what causes a complication, whether it's surgical technique, communication in the operating room or the patient's condition itself, is tormenting," Grantcharov says.

Many surgeons, however, may be uncomfortable with using a black box in the operating room, says Dr. Teodoro Forcht Dagi with the American College of Surgeons Perioperative Care Committee.

"If there was a legal requirement to record every operation, then many surgeons would be resistant," Forcht Dagi says. He says he believes doing so would create a sense of nervousness that would paralyze a surgeon's ability to operate and end up ultimately harming patients.

"The black box needs to be used solely by surgeons for their own education, in which case I think it's a great idea," Forcht Dagi says.

Errors during surgery have generally been dealt with after the fact, and only once a complication during the patient's recovery occurs. Weeks after surgery, cases with complications are presented to a panel of experts, who weigh in on what may have gone wrong during the operation.

Yet in many cases nothing is recorded apart from an audio transcript of the operation, making it tough to identify what caused each complication. The black box would add much needed context.

"I would rush (a black box) into service immediately," says Richard Epstein, professor of law at New York University's School of Law. Since most medical lawsuits end up being "he said, she said" arguments, not knowing exactly what happened in the operating room just adds to the level of distrust, Epstein says.

In the United States, the Healthcare Quality Improvement Act prevents courts from using data that doctors and hospitals use for peer review, a self-regulation process in which experts or "peers" evaluate one another. The law allows doctors to assess each other openly and identify areas for improvement without fear of litigation.

But there are exceptions to this rule, says William McMurry, president of the American Board of Professional Liability Attorneys. For instance, cases where surgeries are recorded but don't receive any peer review can be used in court.

While McMurry says that "keeping patients in the dark about the details of their surgery is never OK," he points out that litigation concerns should not derail use of the black box. It will be an asset to the health care system regardless of whether it can be used in court, he says.

"We care about better health care, and the black box will provide surgeons with the information they need to avoid mistakes," McMurry says. "It's a win-win situation."

The surgical black box will be tested in hospitals in Canada, Denmark and parts of South America in the next few months. Talks are also under way with a number of American hospitals.

If doctors accept it, implementation in U.S. hospitals could happen quickly since the surgical black box isn't considered a medical device and doesn't require approval from the U.S. Food and Drug Administration.

Bottom line, Grantcharov says, is that even after years of practicing medicine, the black box "made me a safer surgeon and a better teacher."

Source: http://www.cnn.com