Calls Grow Louder to Regionalize Congenital Heart Surgery

Patrice Wendling

November 27, 2019

PHILADELPHIA — New research suggests the United States has at least twice the number of congenital heart surgery (CHS) programs it needs, reigniting calls for regionalization of care.

"When you go to a place like France, where all of the patients with congenital heart disease are funneled to three or four centers, and you see the outcomes they have and the amazing results, it makes you realize that regionalization — which translates into more patients at each center — definitely improves outcomes," Carl Backer, MD, with the Ann and Robert Lurie Children's Hospital of Chicago, told | Medscape Cardiology.

The drive to improve quality outcomes by creating centers of excellence for a spectrum of complex cardiac procedures has intensified in recent years, but yielded no easy answers. The debate often pits smaller-volume hospitals against larger referral centers and raises questions about patient access and the best indicators of quality.

Previous work has linked higher program volume with lower adjusted mortality after pediatric cardiac surgery, with one study suggesting an inflection point between 200 and 300 cases per year.

Although almost all institutions fall on the right side of the mortality curve, there are "problem institutions, and the fact that we have too many centers is one of the reasons contributing to this," Backer said to a standing-room-only crowd at the American Heart Association (AHA) Scientific Sessions 2019.

Concerns over higher-than-expected mortality rates and low patient volumes were at the center of this year's firestorm surrounding the pediatric heart surgery program at North Carolina Children's Hospital and the permanent closure in 2015 of a fledgling program at St. Mary's Medical Center in West Palm Beach, Florida.

The Bristol heart scandal, in which at least 30 children died after heart surgery in the late 1980s and early 1990s, rocked the United Kingdom and sparked a series of changes. The National Health Service recommended reducing the number of CHS centers in the island nation from 11 to seven and set standards that every center perform at least 500 cases annually and have 24/7 coverage by four certified pediatric cardiac surgeons.

If the 500-case minimum were applied to the United States, with its 325 million people and an estimated 32,500 CHS operations per year, the country would need only 65 centers, according to Backer, also a professor of surgery at Northwestern University's Feinberg School of Medicine and a past president of the Congenital Heart Surgeon's Society (CHSS).

The United States, however, has at least 150 CHS centers, of which 116 report to the Society of Thoracic Surgeons (STS) national database and another 30 to 40 do not, he noted.

In a separate analysis of STS data by Backer and colleagues, mortality rates were 1.8% for centers averaging 300 cases per year and 3.6% for those averaging 100 cases per year. The mortality difference was accentuated when adjusted for case complexity (1.7% vs 5.4%; < .01).

"That's just taking data that are out there, publicly available to anyone, and saying if you were the parent of a child, would you rather they be operated on at an institution that has less than 2% mortality or one that has greater than 4% mortality. And it just happens that the less than 2% are the high-volume centers that have more than 300 cases," he said when interviewed.

Backer suggested that the goals of "rational" regionalization should be to keep case volumes at a minimum of at least 300 per year, to have at least one program per state that has more than 2  million residents (keeping Hawaii), and to minimize travel distance.

In his home state of Illinois, for example, there are eight CHS centers with annual case volumes in 2016 ranging from 10 cases at Loyola University Medical Center and 15 at the University of Illinois-Chicago to 320 at Lurie's Children Hospital and 210 at Advocate Christ Medical Center. Under Backer's plan, the number of programs would drop to two.

Similarly, the number of pediatric heart centers now at 10 in Texas and Florida and 11 in California would be reduced to six, four, and nine, respectively.

"Theoretically, states could mandate that congenital heart surgery centers must do 'x' number of cases," Backer told | Medscape Cardiology. "Even if you set a low bar, if the state of Illinois said you have to do more than 150 cases, that would eliminate eight programs immediately."

One of the arguments against regionalization of congenital heart surgery is the impact on patient travel times, Tara Karamlou, MD, MSc, a pediatric and congenital heart surgeon at the Cleveland Clinic, Ohio, observed during the same session. "Interestingly, patients are already regionalizing themselves to perceived high-volume centers of excellence," she said.

In an analysis of 153 CHS hospitals in 36 states, Karamlou and colleagues reported that two-thirds of hospitals were located within 25 miles of each other and 55 hospitals performed less than 50 cases per year. About one-quarter of patients traveled more than 100 miles for surgery but 53% bypassed their nearest hospital.

In a subsequent analysis that simulated regionalization, only 37 of the 153 CHS hospitals remained with an idealized annual case volume of more than 310 cases. "Why I say this was idealized is that it minimized mortality; we had a 17% reduction in mortality that translated into about 116 potential lives saved" and "median travel distance was increased by only 40 miles," Karamlou said.

However, if the framework is built on case complexity and only high-risk patients are regionalized, only 26 potential lives would be saved because high-complexity cases comprised just 2,000 of 16,000 patients, she noted.

Unpublished data from the investigators suggest that reducing the number of CHS programs to just 57 would allow for a median of 451 cases per year with median patient travel distances of 35 miles.

Backer told | Medscape Cardiology he received a standing ovation when he discussed regionalizing CHS during his CHSS presidential address, and that an "incredible number" of people requested slides from his AHA presentation.

That said, "I heard via some back channels that some of the smaller centers were not happy with the presentation, which I can understand, but that doesn't change the facts," he added.

As for why centers would cling to a CHS program that treats a dozen or so patients a year, Backer commented, "the unfortunate clear answer is the contribution margin of these patients to the hospital is quite clear. I don't think it is out of line to say that hospital administrators who are looking at the bottom line are very interested in holding on to these patients, despite the fact that it may not be the best thing for the patients."

Even in the United Kingdom's nationalized health system, he noted that the shift in policy after the Bristol experience caused a "revolution," with just two CHS centers closing thus far after the NHS said only those centers failing to meet standards would be shuttered.

"We probably should be establishing standards; the very difficult thing is how we enforce these standards and, in concert with that, should we be lobbying congress, the states, the insurance companies to rationally regionalize congenital heart surgery," Backer concluded.

Backer reports consulting for W.L. Gore & Associates. Karamlou reports no relevant financial conflicts of interest.

American Heart Association (AHA) Scientific Sessions 2019. Presented November 17, 2019.

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