Transvenous left ventricular lead implantation with the EASYTRAK lead system: The European experience

Several independent studies suggest that resynchronization therapy-achieved by left- or biventricular pacing-improves hemodynamics in heart failure pa tients with interventricular conduction disturbances. Delivery of this new therapy in an effective and minimally invasive manner presents technical ch allenges, as transvenous access to the left ventricle is required. Since 19 99, a novel over-the-wire approach combining standard pacing lead and angio plasty technology has been evaluated in several European countries. This ne w left ventricular lead, the EASYTRAK system (Guidant, St Paul, MN), has be en clinically evaluated in 2 phases. The first phase was a clinical investi gation to obtain the CE-mark (i.e. European Commission approval). The secon d phase, which started immediately after the CE-mark was obtained, consiste d of a postmarket surveillance called the European registry. This article r eports on the results of the pre-CE-mark clinical investigation and the pre liminary results of the European registry (first 150 patients). During the pre-CE-mark clinical investigation of the EASYTRAK system, lead performance was assessed in 36 successfully implanted patients. The patients had indic ations for WI-pacing, symptoms of heart failure and significant left ventri cular dysfunction. The left ventricular lead was implanted in conjunction w ith a conventional right ventricular lead and a new heart failure device (C ONTAK TR, Guidant, Brussels, Belgium). Lead measurements (threshold, sensin g, and impedance) were performed at implant and subsequent follow-ups. The stimulation thresholds at 0.5 msec impulse width were acceptable, although (as expected) slightly higher than with standard right ventricular pacing l eeds: 1.39 +/- 1.15 V at implant, 1.72 +/- 1.26 V at predischarge, 1.54 +/- 0.88 V at 2 weeks, 1.38 +/- 0.80V at 6 weeks, and 1.24 +/- 0.73 V at 12 we eks. R-wave and impedance measurements were stable over time. A revision of the EASYTRAK lead was required in 3 patients. No perforations were observe d. During the second phase of the European registry, 150 implants were atte mpted in 63 centers from November 1999 to January 2000. The EASYTRAK was im planted with a pulse generator offering, in addition to resynchronization t herapy, either tachycardia monitoring (CONTAK TR) or implantable cardiovert er defibrillator therapy (CONTAK CD), depending on the patient indication. Over half of the centers involved had not previously implanted the EASYTRAK system. Total implant success rate was 83% (135/ 150), skin-to-skin durati on of the implant wets 169 +/- 81 minutes (range, 53-480 minutes), with a c lear learning curve. Once the coronary sinus was found, the implant success rate was 92%. One lead dislodgment and 2 cases of phrenic nerve stimulatio n were reported. We conclude that the new EASYTRAK lead design for transven ous left ventricular lead implantation seems to be a suitable and safe tool for delivering resynchronization therapy to heart failure patients. (C) 20 00 by Excerpta Medica, Inc.