1. METHODS The EASYTRAK 2 lead was studied along with the CONTAK  RENEWAL  2/4/4HE device in the Device Evaluation of the CONTAK RENEWAL 2/4/4HE with EASYTRAK 2 Assessment of Safety and Effectiveness in Heart Failure (DECREASE-HF) Study Reported lead-related adverse events were classified mainly as dislodgments, elevated thresholds and extracardiac stimulation Lead-related events that resulted in invasive intervention or permanent loss of therapy were classified as complications Lead-related events that did not result in invasive intervention or permanent loss of therapy were classified as observations The frequency of events where programming the LV lead configuration was used to circumvent a complication was calculated in all patients who successfully received the EASYTRAK 2 lead (N=233) Electronic Repositioning TM with a Bipolar Coronary Venous Lead Audrius Bredikis, Baylor College of Medicine, Houston, TX; S. Scott Wiggins, Cardiac Centers of Louisiana, LLC, Shreveport, LA; Imran Niazi, St. Luke's Medical Center, Milwaukee, WI; Ramona Ruble, Guidant Corporation, St. Paul, MN ABSTRACT Background: The EASYTRAK ® 2 lead is a left ventricular coronary venous (CV) lead that is used in conjunction with a Cardiac Resynchronization Therapy with defibrillation (CRT-D) system. In contrast to unipolar leads, this bipolar lead in conjunction with electronic repositioning software allows programming of four pacing and two sensing configurations. The purpose of this retrospective analysis is to determine whether this programming flexibility helps to decrease postoperative complications, requiring surgical lead repositioning. Methods: This bipolar lead is under clinical investigation along with the CONTAK ® RENEWAL ™ 2/4/4HE device in the DECREASE-HF study of CRT- D. Reported lead-related adverse events were analyzed in 233 patients (pts) to determine the frequency of events where an alternate pacing/sensing configuration was used to correct the problem without performing surgical intervention. Results: Of 244 pts attempted or implanted with the bipolar CV lead, 233 (95.5%) were successfully implanted. Pts were characterized as 65% male, mean age 67.2 + 10.2 years, NYHA III (96%), and mean LVEF of 22.6 + 6.9%. Over a mean follow-up of 4.7+2.9 months, lead-related adverse events were reported 61 times in 50 pts (21% of pts). The most frequent lead- related events were extracardiac stimulation (32/61; 52%) and dislodgments (22/61; 36%). Of lead-related events, 23 (38%) required invasive intervention, while 38 (62%) had no invasive intervention performed. Of the 38 events without an invasive intervention, 29 events were deemed clinically resolved by the physician. Of these, 14 (48%) were corrected by re- programming. CONCLUSIONS  The addition of a second (proximal) electrode in the EASYTRAK 2 lead confers the ability to program multiple pacing and sensing configurations  Multiple configurations provide the physician with Electronic Repositioning capability to change the pacing vectors, and may help to reduce complications otherwise requiring surgical intervention OBJECTIVE To determine if the multiple pacing configurations of the EASYTRAK 2 lead offer programming flexibility to treat extracardiac stimulation INTRODUCTION Cardiac Resynchronization Therapy (CRT) involves stimulation of both the right and left ventricles Left Ventricular (LV) stimulation is achieved with an LV lead placed in the coronary vasculature Extracardiac stimulation, including diaphragmatic, chest wall, and phrenic nerve stimulation, is a known occurrence with LV pacing Unipolar LV leads have limited programming options available to overcome extracardiac stimulation and elevated thresholds True bipolar (dual electrode) LV leads have the potential for greater programming flexibility that may help to overcome extracardiac stimulation and elevated thresholds Guidant’s EASYTRAK  2 lead is a new bipolar LV lead with four pacing configurations (Figure 1) and two sensing configurations (LV Tip to RV Coil and LV Tip to LV Ring) PATIENT DEMOGRAPHICS The baseline characteristics of the patient population were typical of a CRT-D indicated population (Table 1) Disclosures Audrius Bredikis, MD………………….Clinical Investigator S. Scott Wiggins, MD………………….Clinical Investigator Imran Niazi, MD……….……………….Clinical Investigator Ramona Ruble …………………………Employee of Guidant Conclusions: A bipolar CV lead, in combination with a compatible CRT device, provides additional programming flexibility and may decrease the need for surgical lead repositioning due to elevated thresholds or extracardiac stimulation. Clinically Resolved Observations Corrected by Electronic Repositioning Adverse Event Total Number of Events Configuration Used to Resolve Event Tip>>CoilRing>>CoilRing>>TipTip>>Ring Dislodgment - Elevated threshold -LV 33--- Elevated threshold – LV211-- Extracardiac stimulation - LV92322 Figure 1: Pacing Configurations Table 1: Patient Demographics RESULTS Of 244 patients attempted or implanted with the bipolar CV lead, 233 (95.5%) were successfully implanted Table 2 displays the breakdown of the most common lead-related observations and complications for patients successfully implanted with the EASYTRAK 2 lead The majority of lead-related adverse events were observations (32 of 52 patients) References 1 PMA P010012 S024 Lead-Related AEObservationsComplications Extracardiac Stimulation 244 Elevated Threshold40 Dislodgment- Elevated Threshold 416 Total3220 Extracardiac stimulation was reported in 28/233 patients Only 4 patients required invasive intervention 24 patients were treated with reprogramming* In 11 patients this included electronic repositioning Elevated Threshold was reported in 4/233 patients 2 patients were treated by adjusting the pacing configuration Lead Dislodgment – Elevated Threshold was reported in 20/233 patients 16 required surgical intervention 3 patients were treated by adjusting the pacing configuration Table 2: Lead-Related Adverse Events Patients Successfully Implanted (N=233) All the available configurations were useful to reprogram around these potential complications See Table 1 of Abstract for details on the configurations used to treat lead-related adverse events * Also includes changing the voltage output and/or pulse width. CharacteristicStatistic Age67 ± 10 Years Gender Male (65%) Female (35%) NYHA Class Class III (96%) Class IV (4%) LVEF 23 ± 7% QRS166 ± 14 ms Etiology Ischemic (62%) Non-ischemic (38%) Conduction Disorder LBBB (93%) Non-specific (7%)