Amaze: a randomized controlled trial of adjunct surgery for atrial fibrillation.

OBJECTIVES: Atrial fibrillation (AF) reduces survival and quality of life (QoL). It can be treated at the time of major cardiac surgery using ablation procedures ranging from simple pulmonary vein isolation to a full maze procedure. The aim of this study is to evaluate the impact of adjunct AF surgery as currently performed on sinus rhythm (SR) restoration, survival, QoL and cost-effectiveness. METHODS: In a multicentre, Phase III, pragmatic, double-blinded, parallel-armed randomized controlled trial, 352 cardiac surgery patients with >3 months of documented AF were randomized to surgery with or without adjunct maze or similar AF ablation between 2009 and 2014. Primary outcomes were SR restoration at 1 year and quality-adjusted life years at 2 years. Secondary outcomes included SR at 2 years, overall and stroke-free survival, medication, QoL, cost-effectiveness and safety. RESULTS: More ablation patients were in SR at 1 year [odds ratio (OR) 2.06, 95% confidence interval (CI) 1.20-3.54; P = 0.009]. At 2 years, the OR increased to 3.24 (95% CI 1.76-5.96). Quality-adjusted life years were similar at 2 years (ablation - control -0.025, P = 0.6319). Significantly fewer ablation patients were anticoagulated from 6 months postoperatively. Stroke rates were 5.7% (ablation) and 9.1% (control) (P = 0.3083). There was no significant difference in stroke-free survival [hazard ratio (HR) = 0.99, 95% CI 0.64-1.53; P = 0.949] nor in serious adverse events, operative or overall survival, cardioversion, pacemaker implantation, New York Heart Association, EQ-5D-3L and SF-36. The mean additional ablation cost per patient was £3533 (95% CI £1321-£5746). Cost-effectiveness was not demonstrated at 2 years. CONCLUSIONS: Adjunct AF surgery is safe and increases SR restoration and costs but not survival or QoL up to 2 years. A continued follow-up will provide information on these outcomes in the longer term. Study registration: ISRCTN82731440 (project number 07/01/34).

Transthoracic real-time three-dimensional echocardiography offers additional value in the assessment of mitral valve morphology and area following mitral valve repair.

AIMS: The accurate postoperative assessment of mitral valve repair is important not only to document operative outcome, but also to confirm the functional morphology of the repaired valve. METHODS AND RESULTS: We assessed 25 consecutive patients following mitral valve repair with transthoracic real-time 3-dimensional echocardiography (RT3DE) and 2-dimensional echocardiography (2DE). We compared the adequacy of the visualization of the mitral valve Carpentier segments, the site of the repair, and the accuracy of planimetry by RT3DE and 2DE in estimating the postoperative mitral valve area (MVA), compared to the Doppler-derived pressure half-time (PHT) value. Inter-observer variability and feasibility were also assessed for RT3DE. Adequate visualization of the mitral valve segments was more frequently obtained by 3DE imaging (163/170 by 3DE vs. 121/170 by 2DE, P < 0.001). In particular, the mitral valve commissures were more clearly identified with 3DE. 3DE also was significantly better at correctly identifying the site of the repaired segment (26/30 by 3DE vs. 19/30 by 2DE, P < 0.05). The difference in MVA (mean difference +/- SD) determined by 3DE planimetry, when compared to PHT was -0.21 +/- 0.46 cm(2) and -0.44 +/- 0.95 cm(2) for 2DE (P = 0.014). Planimetry by 3DE more closely correlated with the MVA calculated by PHT than 2DE planimetry (r = 0.89 for 3DE vs. r = 0.6 for 2DE). Imaging with RT3DE was both feasible, with a mean acquisition time of 4.02 +/- 1.68 min, and data analysis time of 15.82 +/- 3.9 min, and reproducible, with good inter-observer variability for segment scoring with 3DE (kappa = 0.79) and mean inter-observer difference in assessing MVA by 3DE planimetry of 0.18 +/- 0.12 cm(2) (P = NS). CONCLUSION: This study suggests that RT3DE offers additional morphological postoperative data of repaired mitral valves, and increases the accuracy of MVA estimation by planimetry. It is both feasible in a busy echocardiography department and reproducible.

Determinants and assessment of regurgitation after mitral valve repair.

OBJECTIVES: The ability to detect residual regurgitation is important in the management of patients after mitral valve repair. We performed a study of 264 patients to determine the risk factors and to compare the accuracy of clinical assessment with that of echocardiography. METHODS: Operative details and valve pathologic data were obtained from individual patient case notes. Clinical assessment consisted of history, examination, and electrocardiography. The presence of regurgitation was ranked in 7 grades, from none to severe. Transthoracic echocardiography was performed blinded to and independently of clinical assessment on the same visit and was graded similarly. Univariate analyses of demographic, etiologic, and operative variables were performed. Significant factors were entered into a multivariate logistic regression model. Sensitivities and specificities were calculated for each diagnostic modality, and the kappa statistic was used to express agreement. RESULTS: Mean (+/- SE) freedoms from regurgitation at 1 and 5 years were 91.5% +/- 1.7% and 47.5% +/- 3.2%. Factors independently associated with postoperative regurgitation were poor ventricular function (P =.04), increased age (P =.01), and chordal procedures (P =.006). When assessing the presence of regurgitation, auscultation conferred a specificity of 78%, a sensitivity of 77%, and a kappa of 0.43 relative to echocardiography. Electrocardiographic criteria for left ventricular hypertrophy were superior, with a complete specificity of 100% but a low sensitivity of 15%. Agreement within 7 grades of severity was moderate, with a weighted kappa value of 0.42. CONCLUSIONS: The hazard function for regurgitation after mitral repair increases steadily after the third year, with ventricular function, age and chordal procedures as independent risks. Clinical assessment and electrocardiography are excellent in identifying regurgitation, but their agreement is less when grading severity.