Direct results of a prospective randomized study comparing ablation with the nMARQ catheter and the PVAC catheter used with and without a 3D system (MAPER 3D Study).

INTRODUCTION

Our aim was to compare in a prospective randomized study the safety, direct results and periprocedural data of ablation using an nMARQ catheter, a PVAC catheter used with the EnSite system, or a PVAC catheter only under fluoroscopy control.

MATERIAL AND METHODS

One hundred two patients (70 male, 57 ±11 years) with atrial fibrillation (AF) were prospectively randomized to: group 1 - ablation performed with an nMARQ catheter and the CARTO 3 system; group 2 - a PVAC catheter used with the EnSite system; group 3 - ablation with a PVAC catheter without a 3D system.

RESULTS

Complete isolation of 400/402 pulmonary veins (PV) (99.5%). Linear ablation was performed in 23 patients in group 1 (small distance between lines isolating PV), in 3 patients in group 2, in 1 patient in group 3. The superior vena cava was isolated in 1 patient, 9 patients, and 9 patients respectively. Duration of fluoroscopy and dose area product were significantly smaller in group 1 (6.5 ±2.9 min/808.8 ±393.9 cGy/cm vs. 13.6 ±5.6 min/1662.6 ±677.8 cGy/cm and 18.8 ±7.6 min/2327.9 ±975.5 cGy/cm; < 0.001). Procedure duration was shorter in group 1 (82.9 ±18.8 min vs. 101.2 ±19.6 min, < 0.001 and 99.8 ±20.8 min, NS). Contrast injection was necessary in 2 patients in group 1, in 8 patients in group 2 and in all patients in group 3. Because nMARQ is a thermocool catheter, the volume of fluid injection was significantly greater (2348.5 ±543.5 ml vs. 1077.9 ±280.5 ml and 1076.5 ±375.6 ml, < 0.001). There were no periprocedural deaths. We observed no cardiac tamponade, neurological complications and no atrioesophageal fistula during follow-up.

CONCLUSIONS

The lowest radiological exposure was observed during ablation performed with an nMARQ catheter. 3D systems reduced fluoroscopy duration and the necessity of contrast injection. The nMARQ catheter requires injection of a large volume of fluid.