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)

一项前瞻性随机研究的直接结果比较了使用 nMARQ 导管和 PVAC 导管进行消融术,并分别使用和不使用 3D 系统(MAPER 3D 研究)的情况。

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Abstract

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(2) vs. 13.6 ±5.6 min/1662.6 ±677.8 cGy/cm(2) and 18.8 ±7.6 min/2327.9 ±975.5 cGy/cm(2); p < 0.001). Procedure duration was shorter in group 1 (82.9 ±18.8 min vs. 101.2 ±19.6 min, p < 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, p < 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.

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