Baylor St. Luke's Medical Center on Friday announced it has voluntarily suspended its heart transplant program for 14 days.
The decision follows deaths of two heart transplant patients in recent weeks, as well as a news investigation that was critical of the renowned heart program. 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.
In announcing the voluntary suspension, Doug Lawson, CEO of Catholic Health Initiatives Texas Division, which owns St. Luke's, said, "The hospital will use the time to complete a medical review of two recent mortalities in the heart transplant program, while continuing its clinical assessment of the program and recruitment of additional surgical and clinical expertise."
According to a new report from ProPublica's Charles Ornstein and the Houston Chronicle's Mike Hixenbaugh, surgeon Masahiro Ono left St. Luke's for a different job last week.
News report findings
ProPublica and the Houston Chronicle in a series over the past few 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, Ornstein and Hixenbaugh report.
Officials with St. Luke's and Baylor College of Medicine had defended the program, according to Ornstein and Hixenbaugh. Officials said the program under Morgan's leadership had boosted its one-year survival rate to 94% in 2016 and 2017. The program's one-year survival rate was 85% among patients who received a transplant between mid-2014 and the end of 2016, versus a national rate of 91.4%, according to the investigation.
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 report.
James "Lee" Lewis, age 52, received a heart transplant Jan. 2 and died about three months later after experiencing several complications. Operating room equipment didn't work properly at a critical point in the surgery, and the donor heart failed, Ornstein and Hixenbaugh report.
Robert Barron, 67, received a heart transplant on Feb. 27, according to his son. While the transplant appeared successful initially, the donor heart stopped twice, and Barron was left in critical condition. Although Barron made some recovery, he suffered additional complications, and his family decided to withdraw care last month.
Hospitals officials confirmed at least one other patient died in recent weeks. The patient's identity has not been released.
An installment in Ornstein and Hixenbaugh's series also looked critically at Frazier.
Baylor St. Luke's CEO Gay Nord in a message to employees when the news investigation was first published said, "We continue to express strong confidence in our internationally recognized heart-transplant program, despite this morning’s media criticism that we believe … in some cases is inaccurate, incomplete, and does not represent our quality of care or our expertise in this specialized field of heart transplant." However, neither Nord nor the hospital has sought a correction.
Voluntary suspension details
During the suspension, St. Luke's will not accept donor hearts for transplant. The suspension does not affect other heart failure procedures. St. Luke's said it will continue to complete heart pump implants. Other transplant programs will not be affected by the decision, the hospital said in a statement.
According to Lawson, St. Luke's board of directors has convened a special committee to assess the program. In a written statement, Lawson noted, "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." He added, "Our prayers are with the families, as well as all those on the waiting list.”
Further, officials said St. Luke's during the suspension will continue recruiting surgeons "to strengthen the program" (Ornstein/Hixenbaugh, ProPublica/Houston Chronicle, 6/1; Ornstein/Hixenbaugh, ProPublica/Houston Chronicle, 5/24; Pulsinelli, Houston Business Journal, 6/1; Rosenblatt/Associated Press, "NBC News," 6/2).
Here are 5 key tactics to attract and retain transplant patients
Download this briefing to learn how to expand the pipeline of potential transplant patients and engage them across the care pathway.