A double-blind randomised controlled trial on the effect of Tocovid, a tocotrienol-rich capsule on postoperative atrial fibrillation at the National Heart Institute, Kuala Lumpur: an interim blinded analysis.

INTRODUCTION: Post-operative atrial fibrillation (POAF) is associated with poorer outcomes, increased resource utilisation, morbidity and mortality. Its pathogenesis is initiated by systemic inflammation and oxidative stress. It is hypothesised that a potent antioxidant and anti-inflammatory agent such as tocotrienol, an isomer of Vitamin E, could reduce or prevent POAF. AIMS: The aim of this study is to determine whether a potent antioxidative and anti-inflammatory agent, Tocovid, a tocotrienol-rich capsule, could reduce the incidence of POAF and affect the mortality and morbidity as well as the duration of ICU, HDU and hospital stay. METHODS: This study was planned as a prospective, randomised, controlled trial with parallel groups. The control group received placebo containing palm superolein while the treatment group received Tocovid capsules. We investigated the incidence of POAF, the length of hospital stay after surgery and the health-related quality of life. RESULTS: Recruitment commenced in January 2019 but the preliminary results were unblinded as the study is still ongoing. Two-hundred and two patients have been recruited out of a target sample size of 250 as of January 2021. About 75% have completed the study and 6.4% were either lost during follow-up or withdrew; 4% of participants died. The mean age group was 61.44 ± 7.30 years with no statistical difference between the groups, with males having a preponderance for AF. The incidence of POAF was 24.36% and the mean time for developing POAF was 55.38 ± 29.9 h post-CABG. Obesity was not a predictive factor. No statistically significant difference was observed when comparing left atrial size, NYHA class, ejection fraction and the premorbid history. The mean cross-clamp time was 71 ± 34 min and the mean bypass time was 95 ± 46 min, with no difference between groups. There was a threefold increase in death among patients with POAF (p = 0.008) and an increase in the duration of ICU stay (p = 0.01), the total duration of hospital stay (p = 0.04) and reintubation (p = 0.045). CONCLUSION: A relatively low incidence rate of POAF was noted although the study is still ongoing. It remains to be seen if our prophylactic intervention using Tocovid would effectively reduce the incidence of POAF. Clinical Registration Number: US National Library of Medicine. Clinical Trials - NCT03807037. Registered on 16th January 2019. Link: https://clinicaltrials.gov/ct2/show/NCT03807037.

Is rheumatic aetiology a predictor of poor outcome in the current era of mitral valve repair? Contemporary long-term results of mitral valve repair in rheumatic heart disease.

OBJECTIVES: Contemporary experience with mitral valve (MV) repair in the rheumatic population is limited. We aimed to examine the long-term outcomes of rheumatic MV repair, to identify the predictors of durability and to compare the repair for rheumatic and degenerative MVs. METHODS: MV repairs for both rheumatic and degenerative lesions were analysed prospectively from our valve-repair registry. The primary outcomes investigated were mortality, survival, freedom from reoperation and freedom from valve failure. Logistic and Cox regression analyses were performed to define the predictors of reoperation and valve failure. RESULTS: Between 1997 and 2010, 627 consecutive rheumatic MV repairs were performed (46.7% of all mitral repair procedures). The mean age of our study group was 32 ± 19 (range 3-75 years). In-hospital mortality was 2.4% and late mortality was 0.3%. Freedoms from reoperation for rheumatics at 5 and 10 years were 91.8 ± 4.8 and 87.3 ± 3.9%, respectively, comparable with that for degenerative valves at 92.0 ± 1.7 and 91.8 ± 4.8%, respectively (P = 0.79). Freedoms from valve failure for rheumatics at 5 and 10 years were 85.6 ± 2.3 and 72.8 ± 4.6%, respectively, whereas those for degenerative repairs were 88.7 ± 5.1 and 82.4 ± 7.7%, respectively (P = 0.45). Independent predictors for reoperation and valve failure in rheumatic patients were residual mitral regurgitation >2+ and performance of commissurotomy. CONCLUSIONS: The durability of MV repair for rheumatic disease in the current era has improved and is comparable with the outstanding durability of repairs for degenerative disease. Modifications of standard repair techniques, adherence to the importance of good leaflet coaptation and strict quality control with stringent use of intraoperative transoesophageal echocardiography have all contributed to the improved long-term results.

Leaflet extension in rheumatic mitral valve reconstruction.

OBJECTIVES: Type IIIa mitral regurgitation (MR) due to rheumatic leaflet restriction often renders valve repair challenging and may predict a less successful repair. However, the utilization of leaflet mobilization and extension with the pericardium to increase the surface of coaptation may achieve satisfactory results. We reviewed our experience with leaflet extension in rheumatic mitral repair with emphasis on the technique and mid-term results. METHODS: Between 2003 and 2010, 62 of 446 rheumatic patients had leaflet extension with glutaraldehyde-treated autologous pericardium as part of their mitral repair procedure. Their clinical and echocardiographic data were prospectively analysed. RESULTS: The mean age of the rheumatic patients was 20.2 ± 11.7 years; range 3-60 years. Fourty-eight (77.4%) patients had predominant MR, while 22.6% had mixed mitral stenosis and mitral regurgitation (MS/MR). Leaflet extension was performed in the posterior, anterior and both leaflets in 77, 13 and 10% of patients, respectively. Additional repair procedures included neo-chordal replacement, chordal transfer/shortening/fenestration/resection, commissurotomy and papillary muscle splitting. All repairs were stabilized with annuloplasty rings. The follow-up was complete in all patients with a mean follow-up of 36.5 ± 25.6 months. There was no mortality in this series. At the latest follow-up, the MR grade was none/trivial in 64.5 of patients, mild in 22.6, moderate in 6.5, moderately severe in 4.8 and severe in 1.6%. Two patients had redo mitral surgery. At 5 years postoperatively, the estimated rates of freedom from reoperation and valve failure were 96.8 and 91.6%, respectively. CONCLUSIONS: Repair with leaflet extension in rheumatic disease resulted in good early and mid-term outcomes. A wider utilization of this technique may increase the feasibility and durability of repair in complex rheumatic mitral valve disease.