Baylor St. Luke’s Medical Center said Friday it has reopened its storied heart transplant program, two weeks after suspending it to conduct an internal review of two recent deaths.
In a written statement, the hospital said its review of the deaths “did not identify systemic issues related to the quality of the program” but that it had nonetheless reorganized its transplant surgery team, refined the criteria for which patients it would accept for heart transplants, and made other improvements to strengthen the program. It did not provide details.
“After reviewing two recent cases and taking steps to strengthen the heart transplant team, we are confident that the program is ready to move forward and serve the critically ill patients and their families who have placed their trust in us,” Doug Lawson, CEO of Catholic Health Initiatives Texas Division, which owns St. Luke’s, said in the statement. “Our unwavering focus is always to ensure our patients receive the best possible medical care, and in ways that reflect our core values of reverence, integrity, compassion, and excellence.”
The decision to temporarily halt the program came after an investigation by ProPublica and the Houston Chronicle found that it had performed an outsized number of transplants resulting in deaths and had lost several top physicians in recent years.
Friday’s decision means that the program will once again be in a position to accept hearts donated for the 88 patients on its waiting list. As of Thursday, a half dozen were listed as Status 1A, meaning they were in urgent need of a new organ and could receive an offer any day. Twenty-five of the patients on the list are currently inactive, meaning that they are not eligible to receive donor hearts, due to illness or other factors.
Although the program is reopening, St. Luke’s is continuing its efforts to fill several key positions related to the heart transplant program, including a surgeon to replace one who left last month and a vice president to oversee all of the hospital’s transplant operations. The hospital has posted openings for several nursing positions in the heart program.
Also, a special transplant committee of the hospital’s board of directors is exploring “additional processes and changes that could further improve the heart transplant program.” Their work is expected to continue into next year.
In the meantime, St. Luke’s said it has expanded the role of Dr. Gabriel Loor, its surgical director for lung transplants, who will now be co-chief of adult cardiac surgery. The hospital did not address the role that will be played by Dr. Jeffrey Morgan, who it recruited in 2016 as surgical director of its heart transplant and mechanical heart pump program.
The investigation by ProPublica and the Chronicle revealed that multiple St. Luke’s physicians raised concerns about errors during operations and serious surgical complications after Morgan’s arrival, and a few cardiologists began referring some of their patients to other hospitals for transplants.
Morgan, who has defended both his and the program’s performance under his leadership, did not immediately reply to a message seeking comment.
Dr. Paul Klotman, president and CEO of Baylor College of Medicine, said in a written statement that the effort to improve the program won’t stop with its reopening.
“Baylor St. Luke’s believes strongly that improvement is a never-ending process,” Klotman said. “Although this voluntary pause in the program is complete, we will continue to recruit additional surgical and clinical expertise, refine procedures and practices, and implement improvements as soon as we identify opportunities.”
Alexander Aussi, a San Antonio-based transplant consultant, had predicted the program would extend its deactivation beyond 14 days and make more sweeping changes to improve care. Based on his past experience helping programs meet regulatory requirements, he believes St. Luke’s has more work to do.
“I still believe they have an organic issue that is multifactorial,” Aussi said. “It’s not one surgeon or one physician. It’s multiple issues that stemmed from a myriad of problems that culminated in these outcomes we’ve seen at St. Luke’s.”
In recent years, St. Luke’s had some of the worst survival rates in the country for patients in the first year after heart transplants. Six of the 21 patients who received heart transplants in 2015 died.
The program ran into more trouble this year, even as leaders touted its quality in statements to reporters: The pace of transplants slowed dramatically starting in January, and three of nine patients to receive a heart this year have died, prompting the voluntary suspension two weeks ago.
The family of Guadalupe Cantu, the most recent patient to die, said they did not know about the program’s recent track record until they read media reports.
Cantu, a 69-year-old retired oilfield worker from the Rio Grande Valley, received a heart transplant on March 15. He died on May 18, two days after ProPublica and the Chronicle published their findings on the program.
Right after the transplant, doctors told his family that there had been complications with his lungs and he was on a life-support machine for his heart and lungs, said Monica Aleman, his daughter. Cantu began to improve, communicating with his family and participating in physical therapy.
But then, a few weeks after the transplant, he was diagnosed with pneumonia and influenza, she said. “They took him into critical care and a day later, everything started going downhill.” He was reconnected to the life-support machine and it was never removed. “He lasted about two months, more or less, until he passed,” she said.
During that time, he suffered from edema, a swelling caused by excess fluid in the body’s tissues, and his skin began to fall off. “All this time my mom was told that he was going to be fine, to have faith, you know stuff like that, but we started seeing everything get worse and worse and worse and worse,” Aleman said. “It was just horrible.”
Two other patients who had heart transplants this year had died before Cantu.
James “Lee” Lewis, a 52-year-old pipefitter from Bay City, Texas, received a transplant on Jan. 2. Operating room equipment malfunctioned during a key stage of the surgery, and the donor heart failed. Lewis died nearly three months later, on March 23, after undergoing more than a dozen operations and suffering numerous complications, including strokes, serious infections and organ failure. His wife, Jennifer, chronicled her husband’s transplant and drawn-out death on Facebook and shared it with reporters.
Another patient, a 67-year-old bankruptcy lawyer named Robert Barron, received a heart transplant on February 27, his son, Craig Barron, said. The transplant seemed to go well, Craig Barron said, but a couple of days later, the donor heart stopped twice, requiring emergency follow-up surgeries and leaving Robert Barron in critical condition. Barron spent weeks connected to life-support machines and seemed to be recovering gradually, before suffering from serious infections and other complications. He died on May 5.
If St. Luke’s had decided to keep its transplant program closed beyond 14 days, it would have had to meet additional regulatory requirements before it could reopen. That process, intended to protect patients and ensure the most efficient use of limited donor organs, can sometimes take several months, according to experts.
Cardiologists and transplant surgeons across the country have paid close attention to the situation at St. Luke’s, given its strong role in heart surgery history. It was at St. Luke’s that famed surgeon Denton Cooley performed some of the world’s first heart transplants back in the 1960s, and where his protégé, Dr. O.H. “Bud” Frazier, has pursued a lifelong quest to develop a complete mechanical replacement for the human heart.
Aleman said it was traumatic for her family to learn about the program’s problems from news reports after her dad died.
“It was a shock hearing the stories of the other people and how apparently the surgery had gone not right and all of the sudden they started having complications. That’s exactly what happened to my dad too,” she said.
Friday would have been Cantu’s 70th birthday.
