Short-term outcome of Polytetrafluoroethylene Membrane Valve versus Transannular Pericardial patch Reconstruction of Right Ventricular Outflow Tract in Tetralogy of Fallot: a Randomized Controlled Trial

Abstract

Introduction Reconstruction of right ventricular outflow tract during primary repair of tetralogy of Fallot often requires the placement of a transannular patch which results in pulmonary regurgitation (PR). We compared the short-term outcomes of bicuspid polytetrafluoroethylene membrane valve versus transannular pericardial patch reconstruction of the right ventricular outflow tract. Methods Thirty consecutive patients undergoing primary repair of tetralogy of Fallot were randomly allocated to two groups - polytetrafluoroethylene valve (PTFEV) group (n=15) and transannular pericardial patch (TAP) group (n=15). The two groups had similar preoperative demographic characteristics. We compared the short-term clinical and echocardiographic outcomes between these groups. The transthoracic echocardiographic follow-up was performed at one week, one month and six months after surgery. Results The PTFEV group had significantly lower central venous pressure in the immediate postoperative period compared to the TAP group (7.60±2.06 vs . 10.13±1.73, P =0.002). Extubation time was significantly shorter in the PTFEV group compared to the TAP group (12.93±7.55 hrs vs . 22.23±15.11 hrs, P =0.04). PR in the PTFEV group was absent in five patients at 24 hours post-surgery. At the study endpoint, PR was absent in six, trivial in one and mild in eight patients in the PTFEV group compared to TAP group, where all 15 patients had severe PR. Conclusion The bicuspid polytetrafluoroethylene membrane valves significantly decrease the central venous pressure in the immediate postoperative period, facilitate early extubation and, thus, prevent ventilator-related comorbidities. They achieve a high degree of pulmonary competence and do not increase the right ventricular outflow tract gradient in short-term follow-up.

Transannular patch repair of tetralogy of Fallot with or without monocusp valve reconstruction: a meta-analysis

“…Finally, 10 articles were included in our analysis [ 11 – 20 ] (Fig. 1 ), which consisted of 2 randomized controlled trials (RCT) [ 12 , 19 ] while the others were retrospective cohort studies [ 11 , 13 – 18 , 20 ].

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“…There was NO significant difference in the perioperative ventilation duration between the two groups with the standard mean difference of − 13.68 (hour, 95% CI − 31.56–4.20, p = 0.13), although the forest plot revealed that ventilation duration in monocusp group was shorter. Data were obtained from 7 studies [ 11 , 12 , 14 – 16 , 18 , 19 ] and comprised of 254 patients in the monocusp group and 243 in the non-monocusp group for the analysis. An I 2 value of 89% indicated significant heterogeneity in this analysis.…”

“…Forest plot demonstrated the length of ICU stay was significantly shorter in monocusp. Data were obtained from 7 studies [ 11 , 12 , 14 , 16 – 19 ] and comprised of 266 patients in the monocusp group and 205 patients in the non-monocusp group for the analysis. I 2 value of 50% and p- value of Chi 2 of 0.06 indicated no significant heterogeneity in this analysis, and thus, a fix-effects model was used (Fig.…”

“…There was NO significant difference in the perioperative ROVT pressure gradient between the two groups with the standard mean difference of − 0.38 (mmHg, 95% CI − 3.28–2.52, p = 0.80), and forest plot also demonstrated similar RVOT pressure in these two groups. Data were obtained from 6 studies [ 11 , 12 , 14 , 15 , 18 , 19 ] including 238 patients in the monocusp group and 219 patients in the non-monocusp group for the analysis. An I 2 value of 79% and p -value of Chi 2 of 0.0003 indicated significant heterogeneity in this analysis, and thus, a random-effects model was used (Fig.…”

“…Limited by small quantity of included studies and patients, a subgroup-analysis of monocusp materials is difficult to carry out. Another limitation was that TOF patients usually operated in 6 to 24 months, however, to ensure sufficient sample size, some studies with mean operation age nearly ten were included in this meta-analysis [ 14 , 16 , 19 ]. Though analysis of baseline demonstrated no significant difference, operation age might still influence the veracity of the study.…”