Several independent studies suggest that resynchronization therapy-achieved by left- or biventricular pacing-improves hemodynamics in heart failure patients with interventricular conduction disturbances. Delivery of this new therapy in an effective and minimally invasive manner presents technical challenges, as transvenous access to the left ventricle is required. Since 1999, a novel over-the-wire approach combining standard pacing lead and angioplasty technology has been evaluated in several European countries. This new left ventricular lead, the EASYTRAK system (Guidant, St Paul, MN), has been clinically evaluated in 2 phases. The first phase was a clinical investigation to obtain the CE-mark (i.e. European Commission approval). The second phase, which started immediately after the CE-mark was obtained, consisted of a postmarket surveillance called the European registry. This article reports on the results of the pre-CE-mark clinical investigation and the preliminary 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 indications for WI-pacing, symptoms of heart failure and significant left ventricular dysfunction. The left ventricular lead was implanted in conjunction with a conventional right ventricular lead and a new heart failure device (CONTAK TR, Guidant, Brussels, Belgium). Lead measurements (threshold, sensing, 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 leeds: 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 weeks. R-wave and impedance measurements were stable over time. A revision of the EASYTRAK lead was required in 3 patients. No perforations were observed. During the second phase of the European registry, 150 implants were attempted in 63 centers from November 1999 to January 2000. The EASYTRAK was implanted with a pulse generator offering, in addition to resynchronization therapy, either tachycardia monitoring (CONTAK TR) or implantable cardioverter 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 duration of the implant wets 169 +/- 81 minutes (range, 53-480 minutes), with a clear learning curve. Once the coronary sinus was found, the implant success rate was 92%. One lead dislodgment and 2 cases of phrenic nerve stimulation were reported. We conclude that the new EASYTRAK lead design for transvenous left ventricular lead implantation seems to be a suitable and safe tool for delivering resynchronization therapy to heart failure patients. (C) 2000 by Excerpta Medica, Inc.
