PART 5. What are the Lessons Learned (or not!) from the Johns Hopkins All Children’s Hospital and North Carolina Children’s Hospital pediatric cardiac surgery program failures?

“Repairing a heart is a risky business, especially when the organ fails to develop properly in the womb. Any number of abnormalities can arise, from major arteries that grow in the wrong place to pumping chambers that fail to form.

Now, a 2017 U.S. News analysis underscores a crucial factor that can tip the balance between life and death: where the surgery is performed.

The analysis of four years of data from hospitals across the country indicates that 26 percent of deaths – more than 1 out of every 4 – that occur following surgery for the most severe heart defects could be prevented by having the operation performed at hospitals where surgical teams do the greatest numbers of procedures.” (A)

Little has changed, however, since the first research linked volume to outcomes in the 1970s. Smaller surgical programs continue to perform procedures best left to surgeons at more experienced institutions, even when there’s a high-volume hospital nearby.

The reasons for the health care industry’s reluctance to act include the same forces that shape so much else in medicine: prestige and money. Hospitals mindful of their reputation and bottom line encourage doctors to keep patients in-house, rather than referring them to rivals with the experience and resources to care for them. Surgeons also oppose efforts to limit the scope of their practice.

Community leaders, too, may rebel at the notion of closing low-volume services, because lost revenue could threaten a local hospital’s survival. Plus, some smaller hospitals provide high-quality care and get excellent results.

In 2015, U.S. News demonstrated that thousands of lives could be saved each year if patients with certain conditions, including those needing joint-replacement operations, were treated in high-volume settings. Overall, knee-replacement patients who had their surgery in the lowest-volume centers were nearly 70 percent more likely to die than patients treated at the busiest centers. For hip-replacement patients, the risk was nearly 50 percent higher…

Children who need complex congenital heart procedures face a 1 in 5 chance of dying before going home, while the risk for those needing simple repairs is less than 1 percent, says Dr. Jeffrey Jacobs, chief of cardiovascular surgery at Johns Hopkins All Children’s Hospital in St. Petersburg, Florida. Jacobs also leads The Society of Thoracic Surgeons Workforce on National Databases.” (A)

ASSIGNMENT: What are the Lessons Learned from the Johns Hopkins All Children’s Hospital and North Carolina Children’s Hospital pediatric open cardiac surgery program failures? What are the regulatory implications?

First scan Parts 1-4 by clicking on:

 “The U.S. has more than double the number of congenital heart surgery centers that it needs, researchers said here.

Currently, the nation boasts more than 150 such centers: 116 participating in the Society of Thoracic Surgeons (STS) National Database as of 2018, and probably another 30-40 not reporting to it, said Carl Backer, MD, of Ann & Robert H. Lurie Children’s Hospital of Chicago, and former president of the Congenital Heart Surgeons’ Society (CHSS).

Among them are “problem institutions,” outliers with unexpectedly high mortality rates, Backer told a standing-room-only crowd at the American Heart Association (AHA) annual meeting…

The idea is that higher case volume is tied to lower patient mortality in pediatric cardiac surgery, 300 cases per year being the inflection point in one study cited by Backer.

This 300-case threshold held up in a separate analysis by his group, which mined STS data and found that mortality rates adjusted for case complexity came out to 1.7% for centers doing at least 300 cases annually and 5.4% for others with 100 each year (P<0.01).

Regionalizing congenital heart surgery therefore should have the goal of keeping case volumes above 300 per hospital while minimizing travel distance. In addition, policies should allow for at least one program per state that has over 2 million inhabitants, according to Backer.

His magic number: 71 sites scattered across the country.

Currently, Florida and Texas each already have 10 pediatric heart surgery centers — and California 11. In Backer’s plan, this would be reduced to six programs in Texas, four in Florida, and nine in California.” (B)

“A decision on the future of the Sydney Children’s Hospital Network has been delayed four months after an independent review called for urgent action amid protracted conflict over the state’s paediatric heart surgeries.

In July, Health Minister Brad Hazzard held a roundtable of doctors and other healthcare workers from across the state after reviewers said governance issues and tensions between the Randwick and Westmead hospitals needed to be settled “as a matter of urgency”…

A NSW Health spokesman said Professor Henry’s review will make recommendations on the governance and planning of healthcare services for children for the next five years.

“These recommendations will obviously relate to considerations of the governance of the Children’s Hospitals Network and the configuration of paediatric cardiac surgery at the Sydney Children’s Hospital, Randwick and Children’s Hospital at Westmead,” the spokesman said…

Westmead cardiologists believe patients will have better outcomes if cardiac services are focused at one hospital, while doctors from Randwick believe losing cardiac surgery would compromise other services.

“Our message has always been very clear, we believe that cardiac surgery is a vital component of any children’s tertiary referral hospital,” Chair of the Sydney Children’s Hospital Randwick medical staff council Dr Susan Russell said after July’s roundtable.

Most clinicians at that roundtable – including paediatric healthcare workers from rural and regional NSW – agreed the state would be best served with one major children’s hospital providing cardiac surgery services. But medical staff from the Randwick hospital disagreed.” (C)

“Johns Hopkins All Children’s Hospital has hired a familiar face to help it restart its troubled heart surgery unit.

Dr. James Quintessenza will return as the department’s chief surgeon and co-director, hospital leaders announced Tuesday.

Quintessenza, 62, oversaw the pediatric heart surgery department at All Children’s for almost two decades. But he was pushed out after the hospital became part of the Johns Hopkins system…

 “We will spend the next year recruiting additional doctors and staff, including for cardiac intensive care, interventional and fetal cardiology,” Kmetz wrote. “We will take whatever time is necessary to do this right.”..

The announcement comes after a tumultuous 11 months for the hospital and its heart surgery unit.

The Times investigation, published last November, found that the department’s 2017 death rate was higher than any other children’s heart surgery program in Florida had seen in the past decade. Complication rates also spiked, the Times found.

The problems began after Johns Hopkins took over All Children’s in 2011 and started making changes to the heart department. Quintessenza had performed the most difficult surgeries. But the hospital’s new leaders wanted the cases evenly divided among its three heart surgeons.

Frontline workers noticed problems with surgeries performed by the other two surgeons as early as 2015 and raised concerns to their supervisors, the Times reported. But procedures continued as the hospital’s leaders pushed to grow the Heart Institute.

Hospital leaders also made changes to the cardiologists and critical care doctors who worked in the department.

Quintessenza disagreed with the hospital’s leaders, the Times reported. The spike in deaths and complications happened after he left.

After the Times’ investigation, six top administrators resigned, including the hospital’s CEO and the chief heart surgeon who had replaced Quintessenza. Federal and state inspectors identified widespread safety problems throughout the hospital and mandated sweeping changes…

 “We made a mistake, and we need to make sure we help support these families and make it right,” Johns Hopkins Health System president Kevin Sowers told the Times in June.

Quintessenza, who graduated from the University of Florida School of Medicine, was instrumental in growing the All Children’s heart surgery program.

He performed the first pediatric heart transplant there in 1995. Two years later he became the chief of pediatric heart surgery. The heart transplant program was ranked one of the nation’s best in a 1999 federal government review.

After Quintessenza left in 2016, he was quickly hired by Kentucky Children’s Hospital to help restart its pediatric heart surgery program. The hospital had halted surgeries after its death rate increased in 2012.” (D)

“In just three years, Johns Hopkins All Children’s Hospital has tripled the number of babies it treats born with congenital diaphragmatic hernia – a hole in their diaphragm, a life-threatening birth defect.

The St. Petersburg pediatric hospital treated 50 children with congenital diaphragmatic hernia in the third year of its CDH program, up from 16 to 18 patients treated in the first year, said Dr. David Kays, medical director of the program.

About half the patients are from families in Florida, and about half travel from around the United States to St. Petersburg for treatment.

Now, the hospital has a dedicated Center for Congenital Diaphragmatic Hernia, a 15-bed unit that is believed to be the nation’s first inpatient unit dedicated to the treatment of infants and children with condition, said Thomas Kmetz, president of Johns Hopkins All Children’s Hospital.

The center is staffed by an interdisciplinary team and led by Kays, who was recruited to All Children’s in early 2016 from University of Florida. At UF, he treated 321 children over 23 years – about 15 children a year, Kays said at a dedication ceremony Thursday for the new center at All Children’s.

“I came here to build what I thought would be the world’s best program in congenital diaphragmatic hernia,” Kays said. “There was a trajectory to this children’s hospital that was perfect for this program. I couldn’t take this program to Boston Children’s or Children’s Hospital in Philadelphia. There were too many egos to accept me to come in and change the paradigm. But this place was just right. It had the same vision to be a great children’s hospital the way I wanted to build a great program.”..

Kays has a reputation in the pediatric surgical world as a bit of a renegade, “a hard-driving guy with outcomes so great that some people don’t even believe it,” said Dr. Paul Danielson, interim chair of the hospital’s department of surgery.

Danielson describes Kays as a revolutionary, and the CDH unit as truly interdisciplinary.

“It’s not multi-disciplinary, where different specialties come and work together. It’s where different disciplines come together and create their own new discipline,” Danielson said. (E)

“Johns Hopkins All Children’s Hospital in St. Petersburg and Golisano Children’s Hospital of Southwest Florida have entered into an agreement to expand care for kids across Florida’s west coast. The agreement gives providers at both locations access to medical privileges to admit and treat patients. Golisano Children’s Hospital will also be able to take part in pediatric research studies and protocols through Johns Hopkins All Children’s Hospital.

This relationship provides a process for collaboration between the two hospitals, with a focus on increasing access to specialized pediatric care. Through this agreement, Johns Hopkins All Children’s Hospital and Golisano Children’s Hospital will work together to deliver the highest quality care, leverage resources and create better value for families.” (F)

“Three cardiologists from outside the state have reviewed the North Carolina Children’s Hospital pediatric heart surgery program and concluded the program can resume complex pediatric heart surgeries there.

The six-page advisory report released this week by UNC Health Care officials acknowledged that new leadership and investment in the program has helped resolve some of the thornier issues exposed several months ago in a New York Times investigative piece.

The external review panel also highlighted the program’s precarious perch as a smaller-volume pediatric cardiology program aspiring to grow in the shadow of a larger program only miles away at Duke University.

“The current pediatric cardiac surgical volume presents challenges in a number of areas,” according to the report compiled by Catherine Krawczeski, division chief of pediatric cardiology at Nationwide Children’s Hospital Heart Center, Victor Morell, surgeon-in-chief and division chief of the UPMC Children’s Hospital of Pittsburgh’s pediatric cardiothoracic surgery, and Edward Bove, chairman of the University of Michigan medical school’s cardiac surgery department.

The external panel suggests having two pediatric cardiac surgeons at a minimum, able to provide coverage 24 hours a day throughout the year.

UNC averaged slightly fewer than 120 “index pediatric surgeries” in the last year, putting it in a “medium” category in terms of volume. The panel found this “borderline for optimally supporting and maintaining” two full-time pediatric cardiac surgeons…

Meanwhile, the panel noted UNC “must balance” its role as a state hospital and being an important resource for patients with complex needs while also considering whether a referral to another institution might produce a better outcome.

“Complex patients with additional comorbidities that place the patient at higher risk of poor outcome (either surgically or postoperatively) should continue to be carefully evaluated by the medical and surgical teams with referral to another center if deemed appropriate,” the panel stated…

The panel suggested also considering programs that might differentiate UNC from regional competitors, suggesting perhaps a comprehensive multi-disciplinary single care unit that includes cardiac, liver, kidney and neurodevelopment specialists, or an adult congenital heart program, a pulmonary hypertension program or cardio genetics program.” (G)

“Wesley Burks, chief executive of UNC Health Care, reportedly said Tuesday that North Carolina Children’s would be making “further enhancements” to its program, “because we recognize the importance of caring for very sick children with incredibly complex medical problems.”

The health system hasn’t announced a date for resuming surgeries.” (H)

“The federal agency that oversees transplant programs said it would investigate Newark Beth Israel Medical Center after ProPublica reported that the hospital was keeping a vegetative patient on life support for the sake of boosting its survival rate…

The team appeared to tailor medical decisions for at least four patients because of these concerns. In the case of Darryl Young, a heart transplant recipient, members of the medical staff didn’t offer options like hospice care to his family because they wanted to make sure Young lived at least a year after his surgery, according to current and former employees familiar with his care. In an audio recording obtained by ProPublica, Dr. Mark Zucker, the director of the heart and lung transplant programs, told the team at an April meeting, “I’m not sure that this is ethical, moral or right,” but it’s “for the global good of the future transplant recipients.”

In response to the concerns raised by the article, Newark Beth Israel said that it would conduct an “evaluation and review of the program, its processes and its leadership.” It later added that it had hired an outside consultant to perform the review…

Dr. Herb Conaway, a New Jersey assemblyman and chair of the Legislature’s Health and Senior Services Committee, called for the transplant team’s actions to be reviewed. “The implicated doctors must face consequences if the allegations are indeed accurate,” he said in a statement on Friday. “Their actions are a stain on the entire medical community, and they must be held accountable for what they have done to both this patient and his family.”

The editorial board of The Star-Ledger in Newark, which co-published the ProPublica investigation, urged prompt scrutiny of the hospital. “This is astoundingly unethical, and if true, should prompt firings of those involved and a federal and state review,” the board wrote. “The Attorney General’s Office should look into it, too, in case there’s something criminal here.” (I)

“The heart transplant program at Oregon Health & Science University Hospital will resume operations after a yearlong suspension, the hospital announced Aug. 26.

Portland, Ore.-based OHSU voluntarily suspended its transplant program last August after all four of the program’s cardiologists resigned for unspecified reasons.

Since then, OHSU has hired three advanced heart failure cardiologists to join the program. On Aug. 26, the United Network for Organ Sharing approved the program’s new primary physician for heart transplantation, which will allow the transplant program to resume operations.” (J)

“There was a life-threatening mistake at one of the largest hospitals in the Delaware Valley, involving two patients waiting for a kidney transplant. Last week, CBS3 received a tip that a patient at the Lourdes Hospital Transplant Center received a kidney transplant meant for another patient on the waiting list.

The hospital system confirmed that the surgery mix-up did, in fact, take place last week. The two patients have the same name and are around the same age.

After several follow-up conversations with Virtua Health, which took over Lourdes Health System earlier this year, the hospital system admits they gave the wrong person a kidney transplant last Monday.

Officials tell us the organ recipient was in need of a kidney and the surgery was successful. But, they say, the next day a staff member discovered the kidney recipient was out of priority order based on the matching organ donor list.” (K)