Efficacy of posterior pericardiotomy in prevention of atrial fibrillation and pericardial effusion after aortic valve replacement: a randomized controlled trial

Abstract

<p><strong>Aim.</strong> Postoperative atrial fibrillation is one of the most frequent complications in cardiac surgery. The aim of this trial was to evaluate the effectiveness of posterior pericardiotomy in the prevention of postoperative atrial fibrillation and pericardial effusion in patients undergoing isolated primary aortic valve replacement.<br /><strong>Methods.</strong> The trial was approved by the local ethics committee. It included adult patients under 70 y.o. who had signed the informed consent for participation in the study and who were planned to undergo isolated primary aortic valve replacement. Exclusion criteria were a history of atrial fibrillation, hyperthyroidism, amiodarone intake, severe chronic obstructive pulmonary disease, left ventricle ejection fraction less than 30%, the size of the left atrium exceeding 50 mm, active infective endocarditis, the presence of adhesions in the pericardium and/or left pleural cavity and mini-sternotomy. From October 2013 to April 2015 607 patients in our clinic underwent different aortic valve procedures. 507 patients were excluded from the study because of the inclusion and exclusion criteria. The remaining 100 patients were randomized into two groups: 49 patients underwent posterior pericardiotomy and 51 patients made up the control group. In both groups the frequency of postoperative atrial fibrillation, pericardial effusion greater than 5 mm, surgery-discharge time, as well as posterior-pericardiotomy-related complications were studied. Trial number: ISRCTN11129539.<br /><strong>Results.</strong> There were no deaths, stroke or cardiac tamponade during the postoperative stay. Neither were there any complications associated with the performance of posterior pericardiotomy. The incidence of atrial fibrillation, pericardial effusion and average duration of the postoperative stay were similar in both groups: 16% in posterior pericardiotomy group vs 14% in the control group (p=0.71), 10% in posterior pericardiotomy group vs 12% in the control group (p=0.80) and 12.4±4.3 days in posterior pericardiotomy group vs 11.9±4.1 days in the control group (p=0.27), respectively.<br /><strong>Conclusion.</strong> The trial did not confirm the effectiveness of posterior pericardiotomy in preventing postoperative atrial fibrillation and pericardial effusion during the in-hospital period after isolated primary aortic valve replacement in low risk patients. However, further investigations are needed.</p><p>Received 1 December 2016. Accepted 14 February 2017.</p><p><strong>Funding:</strong> The trial was carried out within the dissertation research and according to the research calendar of Kuban State Medical University. There was no additional funding except for the resources allocated for postgraduate scholarships.</p><p><strong>Conflict of interest:</strong> The authors declare no conflict of interest.</p><p><strong>Author contributions</strong><br />Conception and study design: V.I. Kaleda, K.O. Barbuhatti.<br />Data collection and analysis: V.I. Kaleda, S.Yu. Boldyrev, S.A. Belash, I.I. Yakuba, S.S. Babeshko, I.A. Belan. <br />Drafting the article: V.I. Kaleda.<br />Critical revision of the article: V.I. Kaleda.<br />Final approval of the version to be published: V.I. Kaleda, S.Yu. Boldyrev, S.A. Belash, I.I. Yakuba, S.S. Babeshko, I.A. Belan, K.O. Barbuhatti.</p><p><strong>Acknowledgements:</strong> The authors would like to express their gratitude to Cand. Sci. (Engineering) V.P. Leonov (“Biometrika”) for assistance in statistical data processing.</p>

Prophylactic routine posterior pericardiotomy: Should we perform it in every patient?

“…Our randomized controlled trial included patients aged 18-69 years undergoing primary isolated aortic valve replacement. 6 Besides preoperative atrial fibrillation, there was a long list of exclusion criteria, including the majority of known risk factors of atrial fibrillation and conditions that hinder PP performance: a history of thyroid dysfunction, amiodarone intake, pericardial effusion, severe chronic obstructive pulmonary disease, left ventricular ejection fraction <30%, left atrial systolic diameter >50 mm, active infective endocarditis, pericardial and/or pleural adhesions, and minimally invasive approach. Assuming a rate of POAF of 35% (a close number was used in an initial PALACS protocol 7 ), we estimated that a sample size of 90 participants would have provided 80% power and 5% confidence level to detect a reduction of the primary outcome down to 11% (based on our systematic review 8 ) in the PP group compared with the control group.…”

Commentary: A small incision to cut in half postoperative atrial fibrillation

“…In a small randomized trial, Kaleda and colleagues 4 looked at 100 patients undergoing primary isolated aortic valve replacement and found no significant difference in the incidence of POAF between patients who received a posterior pericardiotomy and those who did not (16% in intervention group vs 14% in the control group; P = .71). In addition, postoperative outcomes were similar between the 2 groups.…”