"This intervention is not well known in the surgical community," Dr. Mario Gaudino of Weill Cornell Medicine and NewYork-Presbyterian in New York City told Reuters Health by phone. "It was tested previously in very small trials outside of the US and seemed to be very effective. The data were so promising I said, 'It's probably time to test this intervention in an appropriately powered and rigorously designed trial.'"
The intervention involves making a small incision in the back side of the pericardium and inserting a left pleural drainage tube, which generally is removed a few days after surgery. Excess fluid continues to drain through the slit in the pericardium until it heals on its own.
"There seems to be no harm associated with the technique," Dr. Gaudino said. "Just a small percentage of patients may not be eligible because of an anatomical contraindication such as adhesions in the left pleural cavity or a chest deformity that would make the operation more complex."
"Anecdotally, we have received thousands of emails from surgeons saying they will be changing their practice," he noted. "So while we don't have definitive proof of efficacy yet, surgeons may still want to consider trying it."
As reported in The Lancet and presented at the American Heart Association's Scientific Sessions on Sunday, Dr. Gaudino and colleagues randomized 420 patients undergoing elective surgery on the coronary arteries, aortic valve or ascending aorta to two groups: 212 received a posterior left pericardiotomy and 208 did not. The groups were balanced with regard to clinical and surgical characteristics: median age, 61; 24% women; median CHA2DS2-VASc score, 2.0.
Follow-up was 30 days after hospital discharge.
Three patients in the intervention group did not receive the intervention, and two patients in the intervention group and one in the no-intervention group died during follow-up.
The incidence of postoperative AF was significantly lower in the intervention group (17% vs. 32%; odds ratio adjusted for the stratification variable, 0.44), as was the incidence of postoperative pericardial effusion (12% vs. 21%; relative risk 0.58).
Postoperative major adverse events occurred in six (3%) patients in the intervention and in four (2%) in the no-intervention groups. No complications related to posterior left pericardiotomy were seen.
The authors conclude, "Based on the concordance between the previous evidence and our results, the large treatment effect, and the very favorable risk to benefit ratio of the intervention, posterior left pericardiotomy should be considered during most cardiac surgery operations."
Dr. Mario Pascual, an electrophysiologist at Baptist Health's Miami Cardiac and Vascular Institute in Florida, commented in an email to Reuters Health, "The authors of the study should be commended for this well-designed randomized trial. Pericardiotomy is a simple procedure to (do) during cardiac surgery. I have no concerns related to the procedural technique."
Nonetheless, he added, "I agree that a multicenter trial is needed prior to broad implementation of this technique."
SOURCE: https://bit.ly/3FuxAXb and https://bit.ly/3HzCFPy The Lancet, online November 14, 2021.
By Marilynn Larkin
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