Articles Posted in Surgery

We all owe our individual and collective health not just to ourselves but to any army of Samaritans — our friends, families, colleagues, caregivers, and the many medical professionals who practice at the highest levels of skill and compassion.

It’s tempting, especially when immersed in the ways that health care in this nation falls short, to turn from healthy skepticism to corrosive cynicism. But for this holiday in particular, let’s all give special thanks for those who practice the healing arts. Many of them will leave loved ones and work long hours over Thanksgiving, and not just because of a fee or a charge but to improve the lives of the sick and needy.

With all the adverse, if not hostile reaction Americans are showing in recent days to people beyond our shores, it’s also worth reminding ourselves that the call to help humanity truly is deep and universal. We can learn and be humbled by what others accomplish, including in health and medicine, with resources so much more spare than we can marshal, spending as we do, and, as the Organization for Economic Cooperation and Development notes, at the pinnacle for healthcare and not always seeing equivalent, positive outcomes.

But what if the money just wasn’t there? In Nepal, as New York Times columnist Nicholas Kristof has reported recently, an eye doctor improvises and ends up with a cheap, fast way to restore the sight to tens of thousands of blind people. Western practitioners derided Dr. Sanduk Ruit until his cataract microsurgery was subjected to a randomized trial whose results were published and showed his outcomes, with a 98 percent success rate, were the equal or better of Western counterparts. Further, his procedure costs $25 or so, while published data on cataract surgeries, without costly machines, run more than $3,400 per eye. Ruit has expanded his pioneering technique into a broad practice and it treats more than 30,000 poor across the region, people who otherwise would be doomed to darkness and even greater economic depredation; he charges a small fee to half the patients but treats the others for free.

Meantime, Dr. Devi Shetti also merits mention: He’s an Indian cardiologist who has built a large-scale heart care system that seeks to provide services to those in most dire need but least able to pay with what National Public Radio terms “cardiac care Henry Ford style.” He left a $350,000-a-year practice in Miami to return to his native land, where he tussles with vendors, especially those from the industrial west, about every cost, knowing his patients may be selling their homes or sole source of sustenance (a cow) to cover a loved one’s care. He has shown that prices can be driven substantially lower. He and his five dozen colleagues perform more than 14,000 procedures annually and at a fraction of the cost. Their break even number now, the doctor says, is $1,200 per patient, though he thinks it can go lower; compare that with the United States, where, for example, a bypass procedure in 2013 in the Midwest cost more than $100,000. Those who can pay do but more than half his patients receive cost-free care. Recognizing a huge inequity in a land he clearly loves, the doctor never even discusses payment for girls who are his patients; he knows their parents might otherwise neglect such children solely because of their gender.

Here’s hoping that practitioners like Ruit and Shetti advance their work in helping the needy and poor even more and that their Western counterparts, our caregivers, find due inspiration in their accomplishment.

I’m grateful for the time and consideration my family, friends, colleagues, and clients give to me, my practice and our collective health. Thank you to all on this special holiday.

Thankfully, most doctors are honest, but a pattern of greed and dishonesty has popped up with disturbing frequency around the country: heart specialists putting permanent devices into healthy hearts with no medical justification.  It’s happened in California, Maryland, New Mexico and now in a Chicago suburb, Munster, Indiana.

This town of 23,000,  30 miles southeast of Chicago, now has 293 patients asserting in lawsuits that a trio of heart specialists performed needless procedures, the New York Times reports.

State Medicaid officials, the Times says, have launched an investigation and federal authorities also may be probing the physicians, who make up Munster’s most popular cardiology practice and the highest-paid heart doctors by Medicare reimbursement.

The newspaper examines not only the practitioners and their preferences for certain medical devices and procedures but also the role of a local hospital that benefited from the physicians’ robust activity.

Among the paper’s findings, based on data it shared with a professor of Medicine at the Dartmouth Institute for Health Policy and Clinical Practice: Munster’s rate for defibrillator implants, per capita and after appropriate adjustment for various key factors, was in the top 10 percent for the country for 2010, 2011 and 2012.

The region showed up with some of Indiana’s highest rates per capita for cardiac catheterizations and coronary angioplasties, procedures that, in many cases, can be elective, i.e., optional.

Good advice gets offered in the final line by an unhappy patient who now carries a five-inch chest scar for a surgery and other procedures and medications that are under question now: “Don’t do what I did and depend on the doctor,” she says. “Get a second opinion.”

Of course, that’s easier said than done when a seemingly sincere doctor says you need heart surgery and you may not have a lot of time to dither around with second opinions.  When a doctor uses scare tactics, that’s when it’s even more important to apply the brakes and politely ask about getting a doctor from some unaffiliated medical practice to look things over and give independent advice.

If any work places should be distraction-free, a short list would include the command post for launching nuclear arms, the control tower of a busy airport and the operating room. We have no information about the first two, but a recent study shows that the people working in the surgical suite might be monitoring their smartphones instead of monitoring you.

As (KHN) and the Washington Post reported, “Cellphone use is not generally restricted in the operating room, but some experts say the time for rules has come. In interviews, many described co-workers’ texting friends and relatives from the surgical suite. Some spoke of colleagues who hide a phone in a drawer and check it when they think no one is watching.”

Sometimes a member of the surgical team might be reviewing pertinent medical data on the device, but too often, they’re being used for decidedly nonmedical purposes. As Dwight Burney, an orthopedic surgeon, told KHN/Post, “Sometimes it’s just stuff like shopping online or checking Facebook. The problem is that it does lead to distraction.”

If you’re a baseball pitcher, being distracted might lead to the runner stealing a base. If you’re a surgeon or anesthesiologist, distraction might mean leaving a sponge inside a patient. It might mean forgetting to check a drug dose. Is texting your buddy about a tee time really worth the risk of causing patient harm?

KHN/Post recalled an incident a few years ago when an anesthesiologist in Texas was accused of sending text messages and e-mails on an iPad while his patient’s oxygen levels were dropping. Supposedly, the anesthesiologist didn’t notice the problem for nearly 20 minutes, and the patient died. The woman’s family sued the doctor, and the case settled.

The American College of Surgeons, the American Academy of Orthopaedic Surgeons and doctors who published a paper a few months ago for the American Society of Anesthesiologists have raised the caution flag about phones in the OR. They want clear rules on whether and how such devices may be used. Some people were concerned about the potential for noise or distraction, and others about the possibility that they could transmit microbes and cause infection. (Who washes her iPhone?)

“No federal regulations or industry-wide quality measures address phone use in health-care settings in general or in the OR,” KHN/Post reported. “And no group tracks whether hospitals have adopted rules for cellphone use.”

Sometimes, these cunning little devices turn into tattletales. In June, we wrote about the Virginia man undergoing a colonoscopy whose phone inadvertently recorded the whole procedure when it was left in his pants pocket on a shelf under the operating table. It recorded shocking comments by the anesthesiologist that prompted the patient to file a successful defamation/malpractice lawsuit.

That event was to the patient’s benefit, but when providers are engaged in personal business, it’s more likely to cause harm. Peter Papadakos, a professor of anesthesiology, surgery, neurology and neurosurgery at the University of Rochester, told KHN/Post, “Once we get into or start using our cellphones, we separate ourselves from the reality of where we are. It’s self-evident: If you’re staring at a phone, you’re not staring at the monitors.”

Such behavior was suggested in the sad demise of comedian Joan Rivers. Her doctor supposedly was taking cellphone pictures during Rivers’ procedure, and although the investigation didn’t directly link Rivers’ death to the doctor’s phone use, it was a serious breach of clinical practice and ethics.

In 2012, the ECRI Institute, a nonprofit enterprise devoted to health-care quality, included cellphone distraction among the top 10 risks that technology could pose to patient safety.

Some hospitals are trying to address the situation. The University of Rochester Medical Center, according to the KHN/Post story, requires staff to keep phones silenced when working with patients, and forbids employees to use phones for personal matters when they’re at any “clinical work stations,” not just operating rooms.

Cardiologist Chandan Devireddy at Emory University oversees a catheterization laboratory where patients undergo cardiac procedures. He forbids staffers from checking e-mail or browsing the Internet when patients are present. At least once a year, his department discusses social media and appropriate cellphone use.

“Appropriate,” in many instances might be the assistance a smartphone offers in bringing up patient information, or consulting with colleagues who aren’t present during a surgery.

But how do supervisors know if their teammates are buying books on Amazon or reviewing lab results “unless you’re videotaping or monitoring all persons at any time of the day?” Devireddy said. So how do you retain the utility of the devices without compromising patient safety?

“Our ability to address patient-care issues is much faster,” Devireddy acknowledged. “The idea of eliminating mobile phones is, I think, a very restrictive one.” He believes that hospitals must find a way to cultivate the benefits while keeping staffers from getting distracted.

Life is full of distractions, and whether it’s a cellphone in the OR or a cute kid in the convertible next to your car, it’s up to the person wielding the tool to make sure it’s used properly. If not, in some cases the consequences are life or death.

Research into the healing properties of music isn’t new, but the field of study recently was launched a bit farther with substantial evidence that listening to music before, during or after a surgical procedure helps patients by reducing pain, anxiety and the need for pain medication.

The results of the research published in Lancet involved about 7,000 subjects, and is considered the most comprehensive review so far of how music helps people cope with medical adventures.

The meta analysis (in which the results of multiple studies are reviewed and analyzed) included 72 published, randomized trials examining the effect of music on postoperative recovery in adult patients undergoing various surgical procedures. It was compared with more traditional forms of clinical care or other nondrug interventions, such as massage.

The impressive, significant review showed that, after surgery, patients were notably less anxious after listening to music and reported less pain and a diminished need for pain meds compared with the study subjects who didn’t tune in.

More than 51 million surgical operations are performed annually in the U.S.

Listening to music at any time was beneficial, but seemed to result in even better outcomes if patients listened before rather than during or after surgery. And, as music therapists have known, when patients listen to music that they choose and that they prefer, the results are even better at reducing pain.

Music is so influential, the study found, that if it was played even when patients were under general anesthetic pain levels were reported as lower, although the effects were more significant when they were conscious.

Although music clearly helped patients heal, it did not reduce the length of their hospital stays. But being in the hospital is usually such a lousy experience that anything that makes it better is welcome, whether it’s bringing your own pillow from home, or your iPod loaded with Taylor Swift (or James Taylor, in my case) and Mozart.

As Dr. Catherine Meads, the study’s lead author, said, “Music is a noninvasive, safe, cheap intervention that should be available to everyone undergoing surgery. Patients should be allowed to choose the type of music they would like to hear to maximize the benefit to their wellbeing. However, care needs to be taken that music does not interfere with the medical team’s communication.”

A reasonable point, but because many surgeons like to work accompanied by music piped into the OR, it’s equally reasonable to allow the patient to control the remote, so to speak, especially if it improves outcomes.

Patients who suspect malpractice after they’ve had an unforeseen injury from a surgical procedure quickly learn that the operating room works on a basic “honor system” for reporting errors. If something goes wrong, the surgeon is required to describe the event in his or her dictated report of the operation. Of course, that lets the surgeon control what gets put on paper.

Now there is a budding movement to have cameras in operating rooms record what happens and save the recordings for possible use later — both to educate professionals and as potential legal evidence.

The Washington Post has an article describing a bill introduced in the Wisconsin legislature to require such recordings. The man behind the move is the brother of a patient who died from too much propofol, the same anesthetic drug that killed Michael Jackson.

Reporter Tom Jackman’s article quotes a Toronto surgeon who has invented a device that synchronizes the vital signs recordings of a patient’s pulse etc. with video and audio recordings of what is going on in the OR. Teodor P. Grantcharov, a professor of surgery at the University of Toronto, told the Post:

If we don’t know what we’re doing wrong, we’ll never improve. This is what many other ­high-performance industries have been using for decades.

Lawyers for the medical industry complain that such recordings would “invade the privacy” of surgeons, nurses and others in the OR. But if it could educate surgeons on how to avoid errors and save lives, that seems like a minor quibble that could be worked around. Other practical issues also need to be addressed. But many surgical procedures are already video-recorded, because they are done with tiny cameras inside the body in so-called “minimally invasive” techniques.

So why not just save the recording?

An impressive study published last week strongly suggests that when it comes to a certain kind of breast cancer, early, aggressive intervention has no effect on a patient’s survival 10 years later.

The research in JAMA Oncology reviewed the records of more than 100,000 women. After being diagnosed with ductal carcinoma in situ (DCIS), the women’s overall chances of dying were a little more than 3 in 100 over two decades. Survival rates for women who received treatment beyond a lumpectomy (to remove abnormal cells) were no different from those who had no additional interventions.

The results of the study were widely reported last week. One news source, the Washington Post, wrote, “The findings add to concerns that the ability to detect these lesions through mammograms may be leading to unnecessary mastectomies.”

We blogged about the common overtreatment of DCIS late last year, and the fact that because it’s found during a mammogram, which many women routinely have, diagnoses of DCIS have increased dramatically in recent years. Diagnosis is one thing, treatment is another, and the JAMA study shows that too often one automatically follows the other, which isn’t necessarily the best medicine.

Because DCIS is a noninvasive cancer (often referred to as Stage 0), the best treatment often is just a lumpectomy. When radiation follows that, the study showed, survival rates did not increase, although that procedure did reduce the likelihood that the cancer would recur. “Significantly,” according to The Post, “there was no difference in the survival rates between women with comparable tumors who had a mastectomy and those who had a less-invasive lumpectomy.”

But the fear factor continues to be a powerful motivator for overtreatment. Many women opt for breast removal to get rid of the perceived threat. As Steven Narod, a senior scientist at the Women’s College Research Institute in Toronto who led the JAMA study, told The Post, “That’s really what’s happening in the last 20 years in the U.S. We have created a culture of breast cancer awareness, and we’ve created a countercultural response of fear. When you do a mastectomy, you reduce the fear greatly.”

But you also disfigure people, waste money and resources, and overtreatment generally invites other problems, including infection and unnecessary worry, stress and exposure to radiation.

The study did identify certain patients for whom a more aggressive treatment for DCIS might be best because they have a higher risk of mortality – women diagnosed when they are younger than 35 and black women.

Some oncologists who reviewed the study cautioned that it had limitations. First, it didn’t compare cancer treatments against each other, but analyzed national cancer registry data from two decades. So analysis of individual patients’ treatments weren’t possible, and many physicians won’t change their clinical practice with such a broad-based review.

But for patients like Mary Lou Smith, the study reinforced her instincts. She was diagnosed with DCIS 30 years ago, then again eight years ago. Her doctors, according to The Post, advised her to have her breasts removed as the safest course of action. She declined, instead choosing to have the questionable tissue removed. That was not the typical treatment, and although Smith, now in her 60s, acknowledges her bias against aggressive treatment, she also told the paper that she understands why doctors recommend mastectomy, and why some women choose it.

“There’s a lot of uncertainty in cancer,” she said. “…So the more certainty we can have as patients, the more comfortable we’re going to be.”

Other research has found that although nearly 60,000 women annually undergo surgical treatment for Stage 0 cancers deemed to be a precursor to the full-blown disease, the number of invasive breast cancers (the deadliest) has not decreased. Some studies have indicated that even a lumpectomy might not be necessary for the mildest cases of DCIS, that surgically removing low-grade lesions didn’t increase survival compared with patients who did not have surgery.

The new study brings us around to a point regular readers of this blog will recognize: Screening is so advanced that tumors can be found even if they would never become threats to health. Technology doesn’t necessarily enable us to distinguish between what requires immediate attention and a range of treatment options from what doesn’t.

As The Post put it, “That has generated a polarizing debate about whether cancers are being overtreated and how to pull back.”

Although some people in cardiac distress need invasive procedures to survive, some heart treatments are overused, and the cost continues to mount.

As explained by patient safety advocate John James in his August newsletter, performing angiography on and inserting stents in patients with stable heart disease not only wastes money, but can be unsafe.

An angiogram is an X-ray of blood vessels made visible after the patient is injected with radioactive dye. It’s often prescribed to detect damaged blood vessels and problems affecting blood flow. After an angiogram locates an occluded coronary artery, a stent, or tiny, self-inflating tube can be inserted to open it, and keep it open.

James claimed that “It has been well known for almost a decade that stenting coronary arteries in stable patients is not in the best interest of the patient,” referring to research in the New England Journal of Medicine. He noted that cardiologists have been prosecuted for performing this needless procedure, and that people have died from it.

Still, they’re widely performed, as we have noted, often because providers find them so profitable.

James also reported that many cardiologists fail to fully inform their patients about the value of angiography and stent placement. Apart from the standard risks of invasive procedures, such as pain, bleeding and infection, you’re exposed to radiation; the more images you receive by technology such as CT and MRI scans, the more radiation you receive, and all such exposure is cumulative.

James recounted the story of a middle-aged man who went to an ER after one episode of chest pain (angina). He had felt rushed and uninformed about his situation, and was told by a cardiologist and another physician that he should have a stent inserted to unblock his arteries. He consulted another cardiologist for a second opinion, who prescribed medication and dietary changes (optimal therapy), telling the patient that there was no scientific evidence that invasive procedures such as stents would benefit him. Indeed, the man was much improved within three months.

A study in JAMA Internal Medicine last month looked at the quality of information cardiologists gave to their heart patients whose condition was stable. Only 59 such discussions were reviewed, but the pattern was clear – only about two conversations involving 23 different cardiologists included all seven elements of informed consent. And when those standards were somewhat relaxed, still only about 8 encounters were considered complete. “Overall,” wrote James, “the decision to have angiography with possible stent insertion was inversely correlated with the number of elements of informed consent given by the cardiologist. Optimal medical therapy alone is known to benefit patients, yet this option was not discussed in [3 in 4] encounters.”

If you have heart issues, and your doctor thinks you might be a candidate for one of these procedures, ask as many questions as you need to feel fully informed about the diagnosis, whether it’s considered stable and what are all the risks and benefits of any treatment. Get a second or third opinion if you need to. As James suggested, “Always frame your questioning in terms of your fears rather than in terms of your mistrust of the provider.”

For more information, see the explanation of angioplasty and stent placement published by Johns Hopkins.

A newly launched website tracks the complication rates of about 17,000 surgeons across the country. The idea is to help patients choose the person who’s going to operate on them based on his or her safety and performance records in comparison with their peers.

The database, Surgeon Scorecard, was established by ProPublica, the nonprofit investigative news site. It analyzed 2.3 million hip and knee replacements, spinal fusions, gallbladder removals, prostate resections and prostate removals done between 2009 and 2013 on patients in Medicare, which pays for two out of every five U.S. hospital stays.

Complications directly related to the operations included infections, blood clots, misaligned orthopedic devices and uncontrolled bleeding. ProPublica counted only cases in which the patient died in the hospital or had a complication requiring readmission within 30 days.

The analysis factored in patients’ health and age. To qualify for comparison, surgeons had to have performed a certain number of the given procedure within five years, so that apples could be compared with apples, so to speak. The team analyzed only elective surgeries because they typically involve healthier patients with the best odds of a smooth recovery.

About 11 in 100 doctors accounted for about 1 in 4 complications, but the rates for hundreds of surgeons were double or triple the national average. About 63,000 Medicare patients suffered serious harm, and 3,405 died after they had procedures generally considered low risk.

The cost of complications was considerable: Taxpayers paid hospitals $645 million solely for readmissions (inpatients who had to be readmitted within 30 days of discharge due to complications).

Another important finding was that even when hospitals identify problems with doctors’ competency or practices, significant barriers impair disciplining the poor performers. Their rights of due process prolong what ProPublica deemed even clear-cut cases.

ProPublica’s analysis has some limitations,” it acknowledged. “Patients covered by private insurance were not included, which in some instances omits a substantial portion of a surgeon’s practice. And our definition of complications does not cover other types of patient harm, such as diagnostic errors or readmissions more than 30 days after an operation.”

Among the site reviewers who considered Surgeon Scorecard’s limitations as problematic was the writer of the Skeptical Scalpel blog He or she is a retired surgeon who said that “big data is not enough” to make sweeping comparisons about surgeon competence and safety.

“It took me less than a minute to discover some interesting omissions from the application,” the anonymous blogger wrote. He/she said that one procedure, laparoscopic cholecystectomy (minimally invasive removal of the gall bladder), was the only general surgery procedure listed, and that approximately one-third of the hospitals in his/her state were not surveyed.

“It looks like the problem is that using Medicare fee-for-service data does not yield enough surgeons performing 20 or more cases in some categories such as laparoscopic cholecystectomy for the five years included in the database.”

At one of the biggest hospitals in his/her state, “apparently only one surgeon performed 20 laparoscopic cholecystectomies on fee-for-service Medicare patients in the five years studied; 23 other surgeons were listed as having performed fewer than 20 laparoscopic cholecystectomies on patients in the target population. I don’t see how patients who want to use that hospital for their gallbladder surgery will benefit from the Surgeon Scorecard.”

But he/she understands why ProPublica chose that procedure to review. “They needed to select a procedure that was done frequently enough to yield a sufficient number of cases for analysis. Unfortunately, because of the limitations of the Medicare fee-for-service data and the low complication rate of the procedure, the Surgeon Scorecard is useless for anyone looking to compare general surgeons.”

He/she finds similar shortcomings with prostate surgery, a procedure also chosen because it’s done a lot. But many surgeons of the blogger’s acquaintance also didn’t perform 20 cases on fee-for-service Medicare patients, so they escaped review.

“Perhaps the next iteration of the scorecard will utilize a data set that contains enough patient and surgeon records to make a meaningful comparison.”

Those are valid points. But that doesn’t mean Surgeon Scorecard lacks value for people who want to know about potentially dangerous surgeons before they commit to their care.

Like the surgeon at Baltimore’s Johns Hopkins Hospital, which is renowned for excellence and a commitment to patient safety. He had more complications from prostate removal surgery than all 10 of his colleagues combined even though they performed nine times as many of them.

Like the Florida surgeon who performed spinal fusions at Citrus Memorial, which was rated among the top 100 nationally for spinal procedures, but he had one of the highest rates of complications in the country for spinal fusions. His two colleagues had rates among the lowest for postoperative problems such as infections and internal bleeding.

Like the chairman of surgery and medical director for orthopedics at Chicago’s Weiss Memorial Hospital who had among the nation’s highest complication rates for knee replacement operations.

“It’s conventional wisdom that there are ‘good’ and ‘bad’ hospitals,” according to the ProPublica story, “and that selecting a good one can protect patients from the kinds of medical errors that injure or kill hundreds of thousands of Americans each year.

“But … when it comes to elective operations, it is much more important to pick the right surgeon.”

Many hospitals don’t track the complication rates of individual surgeons, so they can’t exercise any quality control over those who don’t measure up. The government doesn’t track doctors either.

The database reflects the fact that some subpar performers work at elite medical centers considered among the nation’s best, and that some surgeons with impressively low complication rates work at small-town clinics.

ProPublica found that overall complication rates were relatively low, ranging from 2 in 100 to 4 in 100 procedures, depending on the type of surgery. “But experts who reviewed ProPublica’s results say they strongly suggest that the typical surgeon’s rate can and should be significantly lower,” according to the story.

For example, more than 750 surgeons who did at least 50 operations did not record a single complication in the five years covered by the analysis. And more than 1,400 had only one.

Rating sites other than Surgeon Scorecard do exist, but without a report as thorough as ProPublica’s it’s difficult to know exactly how the databases were developed and their shortcomings. One new one was established by Consumers’ Checkbook, a nonprofit whose site enables consumers to type in a Zip code and search for the top-performing surgeons in 14 types of major surgery.

Its ratings also rely on Medicare claims data from more than 4 million surgeries performed by more than 50,000 doctors. Its criteria include death rates, other bad outcomes, such as infections, falls or other complications and recommendations by other doctors
It’s worth a patient’s time to learn about their surgeon’s track record. Certainly George Lynch thinks so. He nearly died from complications after a 2013 knee replacement performed by a surgeon at New York Methodist Hospital who had one of the highest complication rates on knee replacements in New York State.

Lynch contracted multiple postsurgical infections, went into septic shock and almost died. Now, he needs another knee replacement and, as ProPublica reported, “This time, he’s peppering his doctors with questions and said performance data will help guide his choice of a surgeon and a hospital.”

“I’d rather be a difficult live patient,” he said, “than a compliant dead patient.”

Hospitals love new technology and new treatment initiatives because using them can result in better outcomes for patients. But hospitals also like them because they can charge more for an expensive or complicated surgical tool or protocol, and leverage that use for promotional purposes.

Unfortunately, as we’ve often pointed out, new and complicated treatments sometimes don’t work right. Sometimes they’re used by people insufficiently trained. Sometimes they cause grievous harm to patients and qualify as malpractice. So, many policy experts are calling for hospitals to prove they’re capable before they engage in certain surgical practices.

“As the U.S. health-care landscape advances toward rewarding quality rather than quantity, just buying a new high-tech surgical tool or hiring skilled surgeons may not be enough to support offering the new service,” according to a recent story in Modern Healthcare. “Facilities should more frequently be asked to prove not only the ability to achieve good clinical outcomes, but that there is a community demand for the service in the first place, [health quality and policy leaders] say.”

Implementing new surgical programs sometimes is the result of misguided priorities (see our blog about proton beam technology). Devon Herrick, senior fellow at the National Center for Health Policy Analysis, told Modern Healthcare, “They don’t establish [such programs] because they have a competitive advantage or are especially skilled in the area. [They do so] because there are patients who have insurance that will reimburse for these lucrative services.”

He also said that if hospitals don’t compete on price, they probably don’t compete on quality either.

According to the Centers for Disease Control, congenital heart defects affect about 1 in 100 (about 40,000) births per year in the U.S. About 1 in 4 of those babies are sick enough to require surgery. One medical center that performed them for four years suspended elective pediatric congenital heart surgeries earlier this month because of too many poor outcomes.

In those four years, St. Mary’s Medical Center in West Palm Beach, Fla., performed only 132 separate heart procedures on a total of 90 patients after receiving approval by Florida’s Agency for Healthcare Administration in 2011. Florida, Modern Healthcare explained, requires a Certificate of Need (CON) before a facility may expand, offer a new service or purchase certain kinds of equipment.

When St. Mary’s got the approval, it made sure people knew: “No other hospital in Florida has received such approval in more than 15 years,” it announced, claiming that congenital heart defects are fairly common and that local folks could now access the “unique minimally invasive treatment option right here in the local community.”

But given the CDC data, was there ever a demand for this service in this community? As we’ve noted, the more often a provider performs a certain procedure, the likelier it is that its patients will get the best outcomes. “Families and insurers could have sent patients to already established facilities that have specialized pediatric cardiovascular care teams and in some cases average more than 800 of the procedures each year,” Modern Healthcare noted.

“Ask a parent if they would prefer a place that does that many, or one that does one every other week. I don’t think it takes a genius to figure that out,” Dr. Edward Bove told Modern Healthcare. He’s head of the divisions of pediatric and adult cardiac surgery at the University of Michigan Health System, and collaborates with Joe DiMaggio Children’s Hospital, where a few patients from St. Mary’s had been transferred for additional care.

St. Mary’s wanted the cachet and the revenue from pediatric heart surgery, but it appears that it didn’t have the chops, regardless of what the state decided.

In places where hospitals must receive a CON before a new service can be offered, some industry experts believe they should be required to prove that they have the resources to establish a program as well as a sufficiently high volume of such cases in order to remain proficient.

It’s not as if St. Mary’s was surprised that its reach exceeded its grasp. Concerns over its suitability to perform pediatric heart surgeries were raised during public hearings for its CON process. At the time, reported Modern Healthcare, the hospital’s open heart surgery program was expected to generate 64 cases in the first year and 66 cases in the second, both of which are low numbers. Still, the hospital managed only 46 and 44 respectively in those years.

Cardiac surgeons told Modern Healthcare that hospitals doing these procedures must provide specialized cardiac teams around the clock. “You really need an entire city of people, it’s an enormous technical undertaking,” Bove said. “You don’t just go out and hire a surgeon.”

It’s not clear whether St. Mary’s had that expertise. Documents in support of its CON said its on-call policies would enable the rapid mobilization of surgical and medical support for emergency cases, and that the hospital would recruit staff with appropriate experience and training in pediatric open heart surgery.

Legal claims filed last year by at least four families whose infants underwent cardiac care at St. Mary’s accused the hospital of not being able to quickly recognize and treat the complications during and after their surgeries. They alluded to “systematic failures.”

According to Modern Healthcare, The Joint Commission, the nonprofit that accredits U.S. hospitals and conducts unannounced onsite surveys, said the situation at St. Mary’s is something it “will likely take a look at.”

Conventional wisdom would deem that sort of review necessary before a facility performs the surgery. The view from hindsight is much more likely to reveal collateral damage that never should have been inflicted in the first place.

Last year, after a surgical device was determined to raise the risk of spreading aggressive forms of uterine cancer, one manufacturer recalled all of its power morcellators used to remove uterine fibroids. Now, it’s reported that the FBI has been investigating the company, Johnson & Johnson and its Ethicon subsidiary, over the timing of when it knew about the dangers of its product.

Power morcellation surgery had been popular because it was a less invasive way to remove fibroids in the uterus than traditional surgery. Performed laparoscopically (a small incision is made into which the device is inserted), morcellation surgery broke up fibroids into tiny bits that were removed through the incision.

But after it was learned that many women had contracted advanced cancer after undergoing the procedure, the FDA issued morcellation warnings.

Last month, summarized a story that originally appeared in the Wall Street Journal. Reportedly, “a number of sources close to the company and familiar with uterine fibroid surgical device cancer risks say they have been interviewed by the FBI in recent months.”

When Ethicon recalled its power morcellators and stopped making and selling them, it was commanding about three-quarters of that medical device market. The decision to exit the market was made because the company and an FDA panel believed that there was no way to make the devices safe.

But “[r]eports suggest that Johnson & Johnson may have been warned nearly a decade ago about the risks of upstaging undiagnosed cancer with morcellation during uterine fibroid removal surgery,” according to (“Upstaging” means to deem a cancer at a higher, or more invasive, critical level than before.)

That was the opinion of Dr. Robert Lamparter, a pathologist interviewed by the FBI in May, according to the Journal. Lamparter had warned Ethicon in 2006, eight years before the recall, that power morcellators could be life-threatening because they could spread cancer cells that had been unknown to doctors or patients previous to the laparoscopy. “The manufacturer acknowledges he warned them,” said, “and say they responded by trying to change the instructions on the devices to make them safer.”

In November, the FDA announced that it would allow hysterectomy morcellators to remain on the market, but would require substantially stronger warnings about the risk of cancer and indicate that they would be appropriate treatment for fewer patients than had composed the market before the cancer risk was known. As we blogged, it wasn’t a very popular move by the feds.

Since last year, many hospitals have refused to perform procedures using power morcellators, and several insurance companies now decline to cover such operations.

As you might expect, the number of lawsuits over cancer diagnoses after morecellation procedures has grown. They claim that inadequate warnings were provided for consumers and the medical community.

And now, it seems, the FBI is lending credibility to those allegations.

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