Efficacy of a tool combining guide-wire and stylet for the left ventricular lead positioning.

ABSTRACT

AIMS: The left ventricular (LV) lead for cardiac resynchronization therapy (CRT) is usually positioned in the coronary sinus via a stylet-guided or an 'over-the-wire' approach. Recently, a new tool has been developed, the Medtronic Attain Hybrid, that combines guide-wire and stylet features. We assessed its safety and efficacy in comparison with standard tools currently used in clinical practice. METHODS AND RESULTS: Patients undergoing standard CRT device implantation were enrolled in seven Italian centres. In the preliminary phase of the study (Phase I), data were collected during implantation procedures performed with standard tools (three patients per centre). Subsequently, the Attain Hybrid was made available in the centres and data were collected for all consecutive patients undergoing implantation during the following year. A learning phase was considered (Phase II), and the last three patients per centre (Phase III) were used for comparison with Phase I. One hundred and seventeen patients were enrolled 21 patients in Phase I, 75 in Phase II, and 21 in Phase III. Rates of successful implantation were similar in Phases I and III (95 vs. 100%, P=1.000). The pre-defined target vein was reached in 15 (71%) patients in Phase I and in 21 (100%) patients in Phase III (P=0.021). In 10 (48%) procedures during Phase I, LV lead positioning necessitated switching from guide-wire to stylet; this proportion decreased during Phase III (14%, P=0.043). Mean LV positioning time was 16±7 min in Phase I and 11±6 min in Phase III (P=0.040). No adverse events or lead-related complications were detected on implantation or during a follow-up of 6±4 months. CONCLUSION: The Attain Hybrid is safe and effective. It significantly improves target vein accessibility and reduces procedural time in comparison with conventional tools.