A new study that monitored patients who received on-pump or off-pump coronary artery bypass grafting (CABG) over 10 years found there was little difference in outcomes between the two forms of heart bypass surgery. The findings, from the Department of Veterans Affairs Randomized On/Off Bypass (ROOBY) Trial, are published early online in JAMA Surgery.[1]
Surgeons have debated for 20 years over which method is better—traditional on-pump surgery (which uses an extracorporeal membrane oxygenation [ECMO] heart-lung machine to circulate and oxygenate the the blood while the heart is stopped) or off-pump, which eliminates complications potentially caused by ECMO but makes the procedure more technically difficult. Monitoring the post-CABG outcomes of all original ROOBY trial patients, this phase IV clinical trial represents the largest U.S.-based, multi-center, randomized clinical trial comparing off-pump versus on-pump patients.
The researchers tracked more than 1,000 veterans treated with on-pump procedures and more than 1,000 veterans treated with off-pump procedures over 10 years. These veterans are a national cohort from 18 VA Centers. The average age at the time of surgery for both groups was about 63 years old.
Mortality similar for on-pump vs off-pump CABG
According to the authors, no significant 10-year treatment-related differences were documented for any primary or secondary post-CABG endpoint rates. Endpoints included repeat CABG, other heart revascularization procedures, and changes in cardiac symptoms. The death rates at 10 years were 34.2 percent for the off-pump group and 31.1 for the on-pump group.
Although the 10-year outcome rates were not different, the researchers did document a slightly shorter revascularization-free survival period among patients in the off-pump group. Additionally, the median time to death in the off-pump patients was 5.6 years, and the median time to death in the on-pump patients was 6.1 years. Across all study outcomes, moreover, no off-pump advantages were found.
The analyses for cardiac outcomes for these two groups were completed from May 2017 to December 2021.
“While our findings may not settle the ongoing debate about on-pump versus off-pump advantages with CABG, the data is strong to support the notion that for patients who are viable candidates for either procedure, no benefits were found for using an off-pump procedure,” lead author Laurie Shroyer, PhD, professor of surgery in the Renaissance School of Medicine at Stony Brook University and Northport Veteran Affairs (VA) Medical Center WOC Health Science Officer, said in a statement. “As these veterans were nearly all men, the findings should not be generalized to women or non-veterans. Thus, surgeons should choose the best CABG method based each individual patient’s risks and in light of the surgeon’s own technical CABG expertise and post-CABG outcome experiences. In summary, each CABG patient’s care should be customized to meet their unique needs.”
The study authors write that the findings in their report do concur with the 2015 consensus statement by the International Society for Minimally Invasive Cardiothoracic Surgery.[2] That consensus statement says off-pump CABG may be associated with an increased long-term risk of reintervention and death. Yet, the authors found "10-year symptomatic benefit of patients who underwent CABG was not influenced by the treatment approach.”
“These operations were performed at a time when this revascularization approach was considered novel, and it served as an impetus for a few dedicated surgeons to advance it further to become a minimally invasive robotic and often hybrid operation," Thomas V. Bilfinger, MD, a professor of cardiothoracic surgery at the Renaissance School of Medicine who was not involved in the study, said in the same statement. "While it is good to know there is no difference in the long-term outcomes between off and on pump groups, the lasting importance of this research is that it provides a seed to newer procedural developments that will lead to long-lasting beneficial outcomes for today’s patients.”
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Dave Fornell has covered healthcare for more than 17 years, with a focus in cardiology and radiology. Fornell is a 5-time winner of a Jesse H. Neal Award, the most prestigious editorial honors in the field of specialized journalism. The wins included best technical content, best use of social media and best COVID-19 coverage. Fornell was also a three-time Neal finalist for best range of work by a single author. He produces more than 100 editorial videos each year, most of them interviews with key opinion leaders in medicine. He also writes technical articles, covers key trends, conducts video hospital site visits, and is very involved with social media. E-mail: dfornell@innovatehealthcare.com