Five takeaways from The Inquirer’s investigation into CHOP’s innovative lymphatic program

Five-year-old Michael Sylvestre came to the Children’s Hospital of Philadelphia in summer 2022 to undergo a procedure invented at the top-ranked hospital. The Arizona boy was alert and playful when a medical team wheeled him into a procedure room.

He died the next day of procedural complications from the treatment for a rare lymphatic disorder.

The Inquirer found that Michael Sylvestre’s death followed years of previously undisclosed concerns inside a CHOP program that had pioneered a novel treatment for plastic bronchitis, a potentially fatal condition that can occur in children born with heart defects. In these children, fluid from the lymphatic system seeps into the lungs, where it hardens and clogs the airways.

Two Philadelphia doctors, Yoav Dori, a pediatric cardiologist at CHOP, and Maxim Itkin, an interventional radiologist at the Hospital of the University of Pennsylvania (HUP), figured out how to use minimally invasive techniques to plug the lymphatic leaks with medical-grade glue. They performed the world’s first successful procedure in 2013 on a Texas boy.

» READ MORE: CHOP pioneered a lifesaving lymphatic procedure, but some kids died or suffered strokes. Risks were downplayed.

The Inquirer spent four months examining CHOP’s evolving lymphatic’s program, interviewing families, doctors, pathologists, health policy professors, and bioethicists. The investigation also included a review of thousands of pages of court filings, including depositions, expert opinions, and medical records.

The reporting provided a rare look at the invention of a new procedure at one of the nation’s top hospitals. It revealed infighting between the doctors who accused one another of unsafe practices, exposed how CHOP and its doctors downplayed risk of death and strokes when communicating with parents, and shed light on the unavoidable trial-and-error that comes with medical advancement.

Here’s what the reporting found:

CHOP’s Center for Lymphatic Disorders is the largest and most active in the world. Parents of children with lymphatic disorders come to CHOP for procedures from around the U.S. Dori, now the center’s director, has trained doctors worldwide, and many hospitals have started lymphatic programs modeled after CHOP’s.

CHOP says it has performed hundreds of lymphatic intervention procedures on children since the program’s start, and the majority go on to survive a disease that previously had no effective treatment and often resulted in death. Five parents told The Inquirer that CHOP doctors either saved their child’s life or they were grateful to CHOP, even in cases in which their children suffered complications or the procedure failed to resolve lymphatic leaks.

In court records, CHOP disclosed 11 deaths in the 120 children who underwent lymphatic procedures at the hospital from August 2013 through March 2017. Six of the children suffered strokes. The deaths and strokes occurred post-procedure at the hospital or within two weeks of discharge.

Dori and Itkin, the procedure’s pioneers, raised safety concerns about one another to hospital leadership. Their once collaborative relationship soured as CHOP and HUP leaders considered which doctor should lead the new lymphatic program. They questioned each other’s techniques and training as the program grew and their partnership turned competitive.

In a February 2017 memo to CHOP and HUP leaders, Itkin wrote that Dori’s “interventional technique is sloppy and he often takes unjustifiable risks and takes dangerous technical shortcuts.”

Dori said he had similar concerns about Itkin’s lack of knowledge in pediatric cardiology. “Dr. Itkin is not a pediatrician. He doesn’t know anything about congenital heart disease or actually how to take care of children,” Dori said during a 2022 legal deposition in a medical malpractice lawsuit against CHOP.

“It actually became quite unsafe to take care of patients with some of the things that he was doing,” Dori said.

Itkin declined comment for the story. Dori, through CHOP, also declined comment. CHOP did not answer The Inquirer’s question about how the hospital addressed the allegations.

Inside CHOP’s procedure rooms, though most of the patients did well, complications started to mount, according to court records, a CHOP study, and interviews with families.

As doctors experimented with using dye to see intestinal lymphatic leaks more clearly, two children developed several gastrointestinal bleeding.

In October 2016, a glob of glue traveled to the brain of a 7-year-old Florida boy. In March 2017, a 3-year-old Delaware boy suffered a catastrophic stroke after glue migrated to his brain as well; his parents filed a medical malpractice lawsuit that CHOP settled for an undisclosed amount this past spring.

By 2022, when 5-year-old Michael Sylvestre underwent the procedure, at least two children had died at CHOP from post-procedure complications.

In a statement to The Inquirer, CHOP said one adverse outcome is “too many,” but the hospital is committed to saving as many lives as possible.

CHOP described its lymphatic procedure as “low risk” on its website at the time of Michael’s procedure in late June 2022.

Now, the webpage says nothing about potential risks. Early last year, CHOP updated the webpage to remove the section discussing risks and potential complications, according to an Inquirer search of an internet library of archived websites.

In a statement, CHOP said the website “mention of the procedure being low risk was not intended to be misleading.”

“The procedure has a high success rate for lymphatics abnormalities that, before this procedure, had a high death rate,” CHOP said. “However, we constantly update content to reflect the most up-to-date information.”

Four families, including Michael’s, told The Inquirer they believe doctors downplayed the risk of death or stroke. A fifth family alleged in the now-settled lawsuit that they wouldn’t have consented to the procedure had they fully understood the risks.

Christopher L. Smith, the cardiologist who performed Michael’s procedure, told his mother, Hollie Sylvestre, that no child had died from the procedure. That was not true. By then, at least two children had died in the days after a procedure.

A few weeks after Michael’s death, his parents spoke by phone with Smith and David Hehir, the cardiac ICU doctor on duty the night of the boy’s procedure. The doctors allowed the Sylvestres to record the conversation, and the audiotape is part of their public court filings.

» READ MORE: Listen to the heartbreaking phone call between CHOP doctors and the parents of a boy who died: ‘We are so, so sorry’

During the call, Smith clarified that when he told Hollie Sylvestre that no child had died from the procedure, he meant no child had died within 24 hours of one.

“He is my first patient who has died within 24 hours,” Smith said.

Last year, the couple filed a medical malpractice lawsuit against CHOP and Smith. That suit is pending.