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CHICAGO – Endoscopic vein grafting for coronary bypbad grafting (CABG) has not proven to be more dangerous than open harvesting in the hands of experienced operators, confirmed the REGROUP trial .
The combined rates of death, myocardial infarction and repeated revascularization over nearly 3 years were similar between the two strategies, reaching 15.5% with open sampling and 13.9% with endoscopic sampling (HR 1 , 12, 95% CI 0.83 to 1.51), according to Marco Zenati. MD, Veterans Affairs Boston Healthcare System. Decompose, each individual component was also comparable between groups:
- Death: 8.0% vs. 6.4% (HR 1.25, 95% CI 0.81-1.92)
- MI: 5.9% vs. 4.7% (HR 1.27, 95% CI 0.77-2.11)
- Revascularization: 6.1% vs. 5.4% (HR 1.14, 95% CI 0.70-1.85)
The results remained unchanged after multivariable adjustment in the REGROUP trial, presented here at the annual meeting of the American Heart Association (AHA) and published simultaneously online in the New England Journal of Medicine.
Endoscopic venous sampling is intended to reduce complications at the site of sampling and to promote better healing. According to investigators, it is already used in more than 90% of CABG cases in the United States.
Indeed, they found numerically fewer wound complications in the leg with this strategy (1.4% vs. 3.1% open harvest, RR 2.26, 95% CI 0.99-5.15). After the endoscopic vein graft harvest, patients were also less likely to use antibiotics after CABG (4.6% vs. 14.4%, RR 3.15, 95% CI 2.06-4.82) .
Even in the hands of experienced trial experts, randomized patients for endoscopic sampling had a 5.6% conversion rate in open specimen collection.
In 2009, the PREVENT IV trial had suggested that venous sampling by endoscopy was linked to more transplant failures. "Because less experienced fishermen were allowed to participate in the trial, the quality of the ducts could have been compromised, thus helping to speed up the failure of the venous graft and worse clinical outcomes," he said. explained the Zenati group.
Now, their REGROUP trial, which allows vein graft harvesters only by expert endoscopy and having at least 100 cases to their credit with a conversion of less than 5% in open harvest over more than two years. experience, seems to confirm that the safety signal was actually a problem of competence.
"The learning curve for venous graft harvesting is abrupt and you have to be competent to get good results." Inexperienced operators can cause unnecessary stretching and trauma to the vein graft during harvesting, resulting in lesions. the endothelium and premature failure of the vein graft, "according to the newspaper. authors.
"In my opinion, the best approach to vein harvesting is to let the same person do it all the time, I think it should be an experienced technician or operating room nurse and not a trainee." said Steven Goldman, MD. Sarver Heart Center at the University of Arizona in Tucson, member of the trial planning committee.
However, there are also studies (both on valve replacement and on PAC) that indicate no difference in mortality, whether the trainee or the surgeon-badistant is the primary surgeon or first badistant, a- he declared. MedPage today.
"At Duke, we use endoscopic venous sampling for coronary artery bypbad graft surgery in all patients, and in our experience almost all trainees become skilful and independent with proper education and supervision." The "learning curve" n & # It is no different from any surgical procedure and, with gradual advancement and supervision in training, has no impact on patient outcomes, "commented Peter Smith, MD, of Duke University Hospital in Durham. , North Carolina.
REGROUP was conducted in 16 VA heart surgery centers. Patients undergoing elective or urgent coronary artery bypbad (but not emergency) were randomized according to either of the two vein graft sampling modalities (n = 1,150) and were followed up to follow. at a median of 2.78 years. The investigators excluded patients with CAP and those with moderate or severe valvular disease.
The groups were well balanced at first. The study population was virtually all men.
Although the safety of endoscopic venous collection was questioned almost 10 years ago, subsequent observational studies and this randomized trial confirm its safety and efficacy. "Endoscopic sampling will now be considered the standard of care, unequivocal because it is safe, it reduces wound complications and is preferred by patients," said Smith.
Zenati and his colleagues have carried out a "definitive test" according to which endovascular sampling by vein grafting is just as valid as open air sampling for the prevention of major cardiovascular events, concluded the commentator. AHA Marc Ruel, MD, MPH, of the Ottawa University Heart Institute. in Ontario.
"Is this the last trial, I think so," he said.
Regarding the weaknesses of REGROUP, however, "I would say that these centers may have become EVH [endovascular vein-graft harvesting] centers, "commented Ruel, noting their potential loss in open-air sampling skills.He added that the new technique of non-contact pedicled venous graft harvesting – related to better permeability and better results – has not been studied in the trial.
Finally, Goldman pointed out that the investigators did not evaluate the permeability of the graft. "This is important because it will determine if the sampling technique has altered the quality of the vein graft," he said.
REGROUP was funded by the US Department of Veterans Affairs.
Zenati has not revealed any relevant relationship with the industry.
2018-11-11T00: 00: 00-0500
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