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Federal Inspectors Cite St. Luke’s in Houston for Problems in a Heart Transplant

Defibrillator paddles did not work during a patient’s heart transplant in January, and a backup set was not nearby. The transplant ultimately failed, and the patient died two months later. His case was featured in a May article.

An undated family photo of James “Lee” Lewis, his wife, Jennifer, and their two children. (Elizabeth Conley/Houston Chronicle)

This article was produced in collaboration with the Houston Chronicle.

The federal government has cited Baylor St. Luke’s Medical Center in Houston for not having working defibrillator paddles in the operating room during a January heart transplant. The transplant ultimately failed, and the patient died two months later.

During a review this month, the federal Centers for Medicare and Medicaid Services found that “there were not sufficient quantities of emergency equipment (internal defibrillator paddles) immediately available during cardiac (open chest) surgery,” according to a copy of the report provided by the agency at the request of ProPublica and the Houston Chronicle.

The Chronicle and ProPublica reported in May on the death of that patient, James “Lee” Lewis. The surgeon in his case, Dr. Masahiro Ono, said he tried to use a defibrillator to jolt Lewis’ new heart into rhythm during a key stage of the transplant. But the device did not activate, and Ono told reporters he had to pump the organ by hand while staff searched for a backup.

It was two months before Ono or anyone on the hospital staff told Lewis’ wife, Jennifer, that nearly 10 minutes passed before backup equipment was brought into the room.

“I was so frustrated,” Ono said in an interview in April. “I tried my best to preserve the function of the heart but it couldn’t make it. That did happen, and I’m very sorry about that.”

Lewis’ failed donor heart was later replaced with an artificial heart. He endured nearly 20 follow-up surgeries and procedures before dying in March after yet another mishap. During a procedure, a thin wire got sucked into his artificial heart, causing it to malfunction. For the next 45 minutes, according to medical records, Lewis went without normal circulation, likely starving his brain of oxygen-rich blood.

In a statement Tuesday, St. Luke’s spokeswoman Marilyn Gerry said the hospital conducted its own review following Lewis’ initial transplant surgery “and found that necessary equipment and supplies were available during the procedure, adhering to commonly held processes and standards of medical care.”

She said multiple backup defibrillators were nearby and readily available.

“In our subsequent review of the case,” Gerry wrote, “it was determined that the defibrillator paddles — not the machine itself — were the source of the inoperation. We since increased inventories of backup paddles in the sterile surgical core [near the operating room] and enhanced our testing procedures of paddles. This includes not only daily checks of defibrillators and paddles, but additional checks in advance of each relevant surgical procedure.”

These measures go beyond standard requirements, Gerry said.

Lewis was one of three patients who died following heart transplants during the first five months of 2018. The second and third deaths prompted the hospital to suspend the heart transplant program for two weeks in June. Officials said they “did not identify systemic issues related to the quality of the program” but made changes to its staffing and policies when it reopened.

Following a separate review, CMS cut off Medicare funding for heart transplants at St. Luke’s in August after concluding that the hospital had not done enough to correct problems that led to a high rate of patient deaths following transplants in recent years. St. Luke’s is appealing the decision.

In October, the hospital announced the hiring of two surgeons, effectively replacing the surgical director of the program, Dr. Jeffrey Morgan, though he will remain on the hospital’s staff and retain his academic titles at the affiliated Baylor College of Medicine. Ono left St. Luke’s in May to lead a heart transplant program in San Antonio.

The inspection related to Lewis’ surgery was conducted despite the funding cutoff because the hospital itself is still certified to receive Medicare funding and therefore subject to federal requirements. Though the report found the hospital out of compliance with Medicare standards, the violation does not carry a penalty.

The federal report offered more details about what went wrong in the operating room during Lewis’ transplant. Lewis’ new heart began quivering out of sync and “multiple attempts [were] made to defibrillate but defibrillator failed to discharge,” according to medical records cited by inspectors. The paddles were disassembled and reassembled by staff in the operating room and they were successfully used on Lewis.

Later during the surgery, Lewis’ heart again began to show an irregular rhythm. The original paddles failed to go off again and staff “went to the cardiovascular operating room sterile core area to obtain a replacement set of internal defibrillator paddles and none were immediately available.” They ultimately got functioning paddles from elsewhere in the hospital.

In the statement, Gerry said: “It is important to note that the patient was on a heart/lung bypass machine during this time, which maintained blood flow throughout the process. Our prayers continue to be with Mr. Lewis’ family.”

Lewis’ widow, who previously expressed anguish at her husband’s death, declined to comment for this story through an attorney.

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Mike Hixenbaugh is an investigative reporter at the Houston Chronicle. Email him at [email protected] and follow him on Twitter at @Mike_Hixenbaugh.

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