UPDATED on 3/14/2022 – Call for the abandonment of the Off-pump CABG surgery (OPCAB) in the On-pump / Off-pump Debate, +100 Research Studies
Curator: Aviva Lev-Ari, PhD, RN
UPDATED on 3/14/2022
Debate over? On-pump CABG, off-pump CABG lead to similar 10-year outcomes
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.”
References:
Related CABG Content:
Still No. 1: CABG outperforms FFR-PCI when treating CAD
New ACC/AHA guidelines detail updated recommendations for PCI, CABG
CABG still the ‘treatment of choice’ for patients with complex three-vessel CAD
PCI and CABG for left main CAD associated with similar all-cause mortality rates
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The curator shadowed Dr. J. Walker @MGH performing On-pump CABG in 1/2005 and On-pump CABG performed @Texas Heart Institute in 2/2005, and attended demos of ECMO at Vanderbilt Medical Center, Department of Surgery, Perfusion Program, 8/2005
Public release date: 22-Jul-2013
Contact: Gina Orlando
gina.orlando@bmc.org
617-638-8490
Boston University Medical Center
BMC surgeon recommends off-pump coronary artery bypass grafting be abandoned
(Boston) – In a Special Report in the current issue of Circulation, Boston Medical Center cardiothoracic surgeon Harold Lazar, MD, has found that off-pump coronary artery bypass graft (OPCAB) surgery has failed to show any significant improvement in short-term morbidity or mortality as compared to the traditional on-pump coronary artery bypass graft (CABG) surgery. He recommends that the technique be abandoned, unless surgeons who perform off-pump surgery can show that their own results are as good as results reported with the traditional on-pump surgery.
During off-pump coronary artery bypass graft surgery, the heart is still beating while the graft attachments are made to bypass a blockage. While performing on-pump CABG surgery, the heart is stopped and a heart-lung machine takes over the work for the heart and lungs. This method has been an effective, safe and time-proven technique and is considered the gold standard with which all other surgical revascularization methods have been compared. However, performing coronary revascularization this way can result in myocardial ischemic injury, neurocognitive deficits, and strokes and activate inflammatory pathways that contribute to pulmonary, renal and hematologic complications.
In order to accurately compare the advantages and disadvantages of OPCAB and to determine what, if any, role it should have in the practice of surgical coronary artery revascularization, Lazar examined clinical data from numerous studies worldwide and found the OPCAB technique had failed to show any significant improvement in short-term morbidity or mortality.
According to Lazar a major impetus for performing OPCAB was to avoid the possible detrimental effects of cardiopulmonary bypass, which include activation of inflammatory pathways, changes in neurological and cognitive function and alterations in quality of life. “However, patients undergoing OPCAB have not shown any benefits in these areas,” said Lazar, a professor of surgery at Boston University School Medicine. “Even in those studies in which OPCAB has resulted in a small improvement in early postoperative outcomes, these improvements are no longer apparent on long-term follow-up,” he added.
In fact, several studies suggest that long-term survival may be significantly reduced in OPCAB patients compared with patients in whom on-pump techniques were used. Lazar explains that this may be attributable to the significant increase in incomplete revascularization seen in OPCAB patients and may be responsible for the increase in recurrent angina and need for revascularization procedures seen in OPCAB patients.
“Unless individual surgeons can demonstrate that they can achieve short- and long-term outcomes with OPCABG that are comparable to on-pump CABG results, they should abandon this technique,” said Lazar.
The debate over abandoning off-pump CABG surgery
JULY 29, 2013 Michael O’Riordan
In the July 23, 2013 issue of Circulation, Dr Harold Lazar (Boston Medical Center, MA) argues that the primary focus of surgical coronary revascularization is complete revascularization and a technically perfect anastomosis that uses the best conduits with a minimal amount of hemodynamic instability. He adds that the procedure should be able to be performed “under all circumstances, on all patients, at all institutions, regardless of their cardiac volume.
“We must not forget that patients are sent for surgical revascularization because medical management has failed, their cardiologists believe that stents will not result in complete revascularization, and the goal is for optimal long-term survival and enhanced freedom from recurrent angina and the need for [repeat] revascularization,” writes Lazar. “These goals can be best achieved with on-pump CABG surgery.”
Dr Robbin Cohen (University of Southern California, LA), on the other hand, said that many physicians are routine off-pump CABG surgeons and the data suggest that results achieved by experienced operators are excellent. It is also a cheaper operation in experienced hands. He does not believe that OPCAB should be abandoned but acknowledged there is a need to better identify the ideal patient who would benefit from the procedure.
While there is yet no consensus and no studies have identified subgroups with better results, the ideal OPCAB candidate is one with a severely diseased descending aorta and those with single-vessel or two-vessel disease—in other words, a patient with favorable anatomy that doesn’t require moving the heart around too much, he said.
“I don’t doubt that I have treated some patients with off-pump surgery where if I had put them on the pump I would have killed them,” Cohen told heartwire.
Looking at the big picture
In his perspective, Lazar analyzes previously published retrospective studies and prospective, randomized controlled clinical trials, including the Randomized On/Off Bypass (ROOBY), Smart Management of Arterial Revascularization Therapy (SMART), and Coronary Artery Bypass Surgery Off- or On-Pump Revascularization (CORONARY) studies.
In ROOBY, the primary short-term end point of death and major cardiovascular events at 30 days was similar in the on-pump and off-pump treatment arms, while cardiac-related mortality and major adverse events were higher in the OPCAB arm at one year. The SMART trial also failed to show a mortality benefit with OPCAB. The CORONARY investigators reported no difference in the composite of death, nonfatal cerebrovascular accidents, nonfatal MIs, or new renal failure requiring dialysis between OPCAB and on-pump CABG surgery. In CORONARY, there was also no difference in quality-of-life scores and neurocognitive function at one year.
Importantly, Lazar says the data from published meta-analyses show that OPCAB patients tend to receive fewer grafts and have a higher incidence of incomplete revascularization. “Despite advances in stabilizers and other equipment, it may be difficult to graft inferior and posterolateral vessels because of right and left ventricular distension and hemodynamic changes,” he writes.
Abandoned? Not so fast, says another expert
So, will OPCAB be abandoned? Not likely, says Cohen. OPCAB is performed often in other countries, mainly because the procedure is quicker and has lower costs than conventional CABG surgery. Cohen had high praise for the systematic review by Lazar, however, noting that the OPCAB vs on-pump CABG debate is a complicated topic and nearly each month brings a new review, journal article, or other analysis in the medical journals.
“Early on, most of us assumed that the morbidity associated with cardiac surgery, that being stroke, renal failure, and so on, was the result of cardiopulmonary bypass,” said Cohen. “And when we started doing off-pump procedures, we assumed that the morbidity would be eliminated. That wasn’t the case. Some of the early studies showed an advantage with blood use and sometimes with the utilization of resources, but morbidity and mortality with the two surgeries were the same.”
Cohen addressed the criticism that OPCAB provides incomplete revascularization compared with on-pump CABG and that the anastomoses are not as good, saying these are all valid criticisms of the procedure. He agreed with Lazar’s point that if surgeons must cross over from OPCAB to conventional bypass, the outcomes are poor. To date, however, OPCAB “has been a moving target,” he added, noting that there has been a move toward addressing these shortcomings.
At one point, Cohen said his group was performing up to 90% of cardiac surgeries with OPCAB but now do just 10% of procedures off-pump. The reasons for decline in use include all of the previously cited reasons:
- incomplete revascularization,
- poorer anastomoses, and
- no reduction in morbidity and mortality to show it is better than conventional CABG, as well the fact that
- it is difficult to teach to residents.
For OPCAB to move forward, he said that research needs to provide evidence that the procedure is as least as effective and as durable as on-pump CABG. There is also a need to identify specific patient subgroups that would benefit from OPCAB, such as
- older patients, those with
- existing renal failure, or
- patients who have previously had a stroke.
Source
Related links
- Off-pump/on-pump CABG: Still no consensus
[Interventional/Surgery > Interventional/Surgery; Mar 11, 2013] - CORONARY analysis: High-risk patients do better with off-pump CABG
[Interventional/Surgery > Interventional/Surgery; Nov 03, 2012] - CORONARY: Off-pump and on-pump CABG give similar short-term outcomes
[Interventional/Surgery > Interventional/Surgery; Mar 26, 2012] - New data suggest off-pump CABG has higher mortality than on-pump
[Interventional/Surgery > Interventional/Surgery; Oct 03, 2011] - Short-term benefits of off-pump bypass surgery off-set by long-term risks in Beijing study
[Interventional/Surgery > Interventional/Surgery; Apr 27, 2010] - Off-pump CABG shows no benefit over on-pump approach: ROOBY study
[Interventional/Surgery > Interventional/Surgery; Nov 04, 2009]
Lazar and Cohen report no conflicts of interest. |
REVIEWS in
http://www.ncbi.nlm.nih.gov/pubmed?linkname=pubmed_pubmed_reviews&from_uid=23877063
Should off-pump coronary artery bypass grafting be abandoned?
Lazar HL.
Circulation. 2013 Jul 23;128(4):406-13. doi: 10.1161/CIRCULATIONAHA.113.003388. No abstract available.
- PMID: 23877063 [PubMed – in process]
Off-pump coronary artery bypass grafting: simple concept but potentially sublime scientific value.
Ngaage DL.
Med Sci Monit. 2004 Mar;10(3):RA47-54. Epub 2004 Mar 1. Review.
- PMID: 14976442 [PubMed – indexed for MEDLINE]
Salzberg SP, Adams DH, Filsoufi F.
Curr Opin Cardiol. 2005 Nov;20(6):509-16. Review.
- PMID: 16234622 [PubMed – indexed for MEDLINE]
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Raja SG, Berg GA.
Indian Heart J. 2007 Jan-Feb;59(1):15-27. Review.
- PMID: 19098331 [PubMed – indexed for MEDLINE]
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Noora J, Puskas JD.
Curr Opin Cardiol. 2006 Nov;21(6):573-7. Review.
- PMID: 17053406 [PubMed – indexed for MEDLINE]
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Raja SG, Amrani M.
Expert Rev Cardiovasc Ther. 2010 May;8(5):685-94. doi: 10.1586/erc.10.14. Review.
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Halkos ME, Puskas JD.
Surg Clin North Am. 2009 Aug;89(4):913-22, ix. doi: 10.1016/j.suc.2009.06.015. Review.
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I actually consider this amazing blog , âSAME SCIENTIFIC IMPACT: Scientific Publishing –
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