Baylor St. Luke's Medical Center on Friday resumed its heart transplant program as planned after a voluntary suspension earlier this month.
St. Luke's on June 1 announced a voluntary suspension of its heart transplant program for 14 days. St. Luke's is where famed surgeon Denton Cooley in the 1960s completed one of the first heart transplants. At St. Luke's, O.H. Frazier—Cooley's protégé—has sought to develop a total mechanical replacement for the human heart.
The decision to suspend the program followed deaths of two heart transplant patients in recent weeks, as well as a news investigation that was critical of the renowned heart program. In addition, surgeon Masahiro Ono left St. Luke's for a different job shortly before the suspension was announced.
ProPublica and the Houston Chronicle in a series in recent weeks reported that St. Luke's heart transplant program completed "an outsized number of transplants" that resulted in deaths in recent years and had several leading physicians depart. In addition, colleagues voiced concerns to hospital leaders about the program's direction under Jeffrey Morgan, who took over as surgical director in 2016, ProPublica's Charles Ornstein and the Houston Chronicle's Mike Hixenbaugh report.
Officials with St. Luke's and Baylor College of Medicine had defended the program, citing improvements in its one-year survival rate, according to Ornstein and Hixenbaugh. However, out of nine patients who had heart transplants at St. Luke's this year, at least three have died, according to interviews with patients' family members, information provided by the hospital, and United Network for Organ Sharing data, Ornstein and Hixenbaugh reported.
When the suspension was announced, Doug Lawson, CEO of Catholic Health Initiatives' Texas Division, which owns St. Luke's, said, "Although extensive reviews are conducted on each unsuccessful transplant, the recent patient outcomes deserve an in-depth review before we move forward with the program."
St. Luke's on Friday announced it has reactivated the program.
St. Luke's in a written statement said the review "did not identify systemic issues related to the quality of the program."
Lawson said, "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."
The hospital said it has introduced several changes to the program. For instance, St. Luke's said it has incorporated new "parameters and benchmarks" for selecting patients for the heart transplant waiting list and has "streamlined" daily rounds.
The hospital has also convened a special committee to study other changes it could make to improve the program and ensure that it communicates transparently with patients and their families, St. Luke's said in a statement.
Further, the hospital is broadening the role of Gabriel Loor—the hospital's top lung transplant surgeon, according to Ornstein and Hixenbaugh—to include working directly with the heart program's surgical director, Jeffrey Morgan. Loor has performed "more than 20" heart transplants, according to St. Luke's.
In addition, St. Luke's is recruiting two more cardiac surgeons, according to Ornstein and Hixenbaugh.
Paul Klotman, president and CEO of Baylor College of Medicine, in a statement said, "Baylor St. Luke's believes strongly that improvement is a never-ending process." He continued, "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."
Consultant disputes readiness
Alexander Aussi, a San Antonio-based transplant consultant, had forecasted the suspension would last longer than 14 days and that St. Luke's would make major changes to improve care. He said he thinks St. Luke's has more work to do, according to Ornstein and Hixenbaugh. "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."
Lawson, however, expressed confidence that any problems had been resolved: "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," he said (Ornstein/Hixenbaugh, ProPublica/Houston Chronicle, 6/15; AP/Modern Healthcare, 6/15).
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