Comparison of cardiac surgery with left atrial surgical ablation vs. cardiac surgery without atrial ablation in patients with coronary and/or valvular heart disease plus atrial fibrillation: final results of the PRAGUE-12 randomized multicentre study

Abstract

AimsSurgical ablation procedure can restore sinus rhythm (SR) in patients with atrial fibrillation (AF) undergoing cardiac surgery. However, it is not known whether it has any impact on long-term clinical outcomes.Methods and resultsThis multicentre study randomized 224 patients with AF scheduled for valve and/or coronary surgery: group A (left atrial surgical ablation, n = 117) vs. group B (no ablation, n = 107). The primary efficacy outcome was the SR presence (without any AF episode) during a 24 h electrocardiogram (ECG) after 1 year. The primary safety outcome was the combined endpoint of death/myocardial infarction/stroke/renal failure at 30 days. A Holter-ECG after 1 year revealed SR in 60.2% of group A patients vs. 35.5% in group B (P = 0.002). The combined safety endpoint at 30 days occurred in 10.3% (group A) vs. 14.7% (group B, P = 0.411). All-cause 1-year mortality was 16.2% (A) vs. 17.4% (B, P = 0.800). Stroke occurred in 2.7% (A) vs. 4.3% (B) patients (P = 0.319). No difference (A vs. B) in SR was found among patients with paroxysmal (61.9 vs. 58.3%) or persistent (72 vs. 50%) AF, but ablation significantly increased SR prevalence in patients with longstanding persistent AF (53.2 vs. 13.9%, P < 0.001).ConclusionSurgical ablation improves the likelihood of SR presence post-operatively without increasing peri-operative complications. However, the higher prevalence of SR did not translate to improved clinical outcomes at 1 year. Further follow-ups (e.g. 5-year) are warranted to show any potential clinical benefit which might occur later.

2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS

“…Wiele badań obserwacyjnych wskazuje na praktyczne możliwości i bezpieczeństwo chirurgicznego zamykania/wyłączania LAA, ale dostępne są jedynie ograniczone dane z kontrolowanych prób klinicznych [461][462][463][464]. Rezydualny przepływ w LAA lub niepełne wyłączenie LAA może zwiększać ryzyko udaru mózgu [465].…”

“…W następstwie zabiegu labiryntowania według Coxa wytworzony więc zostaje elektryczny labirynt (maze), w którym pobudzenie z węzła zatokowo-przedsionkowego znajduje drogę do węzła przedsionkowo-komorowego, a jednocześnie zapobiega się przewodzeniu migoczącemu. Zabieg labiryntowania według Coxa oraz inne, często prostsze, metody chirurgicznego leczenia AF wykonuje się głównie u pacjentów poddawanych innej operacji na otwartym sercu [461,466,[784][785][786][787][788][789][790][791][792][793][794][795][796][797][798]. W przeglądzie systematycznym zamówionym na potrzeby niniejszych wytycznych stwierdzono, że chirurgiczne leczenie AF przy okazji innej operacji kardiochirurgicznej zwiększało odsetek pacjentów bez AF, trzepotania przedsionków lub częstoskurczu przedsionkowego w porównaniu z niestosowaniem takiego leczenia (RR 1,94; 95% CI 1,51-2,49; n = 554 w 7 RCT) (dodatkowa ryc.…”

2012 HRS/EHRA/ECAS Expert Consensus Statement on Catheter and Surgical Ablation of Atrial Fibrillation: Recommendations for Patient Selection, Procedural Techniques, Patient Management and Follow-up, Definitions, Endpoints, and Research Trial Design

“…1290 Several other RCTs and meta-analyses are available to evaluate AF surgery at the time of concomitant mitral procedures. 1327,1328,1329,1330,1331,1332,1333,1334 Large LA, AF duration, advanced age, and failure to isolate the entire posterior LA are common predictors of reduced long-term efficacy. High baseline comorbid risk is a common reason cited for not performing surgical ablation, though many institutional studies note that this is not a contraindication to surgical ablation.…”

Incomplete surgical ligation of the left atrial appendage—time for a new look at an old problem

“…LAAOS III-a large, randomized prospective trial designed to compare the efficacy of LAA closure for stroke prevention using excision versus stapled closure, to no closure at all (21)-may ultimately address this issue. For now, the findings from the PRAGUE-12 study (22) seem to provide preliminary support in favor of complete LAA closure. This study found that the incidence of stroke among those who underwent LAA surgical excision in conjunction with AF surgery was 2.7% at 1 year, as compared to 4.3% in the control arm.…”