Study to Determine the Safety and Feasibility of Utilizing the CD Leycom Pressure/Conductance Catheter to Determine Optimal LV Pacing Site
Study to Determine the Safety and Feasibility of Utilizing the CD Leycom Pressure/Conductance Catheter to Determine Optimal LV Pacing Site
It is hypothesized that it is both safe and feasible to use an interventional approach to LV
 lead placement (placing the LV lead guided by acute hemodynamic measurements), and that the
 LV lead can be placed in a position that is superior to the initial empiric lateral wall LV
 lead location in less than 30 minutes without significant risk to patients. The time from RV
 capture to LV activation correlates with the optimal pacing site based on stroke volume &
 dP/dt measurements.
Background

 Cardiac synchronization therapy (CRT) is recognized as effective adjunctive therapy for heart
 failure; however, up to 40% of patients who undergo CRT device placement do not have a
 favorable response to therapy and are labeled non-responders. The lateral wall of the left
 ventricle (LV) is generally regarded as the optimal site for LV lead placement and some
 non-responders with LV leads not on the lateral wall can be converted to responders by
 repositioning the LV lead to the lateral wall. However, recent studies indicate that in some
 patients LV lead placement at a site other than the lateral wall may result in a better
 response to CRT. In such circumstances, empiric lateral wall lead positioning/repositioning
 may expose patients to the risks of another invasive procedure (including an increased risk
 of infection); in the case of lead repositioning to improve response to CRT the additional
 risk is doubled, as there is no certainty that the new position will be superior to the old.

 Several investigators have used the acute hemodynamic response to biventricular pacing to
 determine the optimal LV lead position. To make these measurements some groups used a Millar
 pigtail catheter (Millar Instruments, Houston, Texas) while other groups used real-time
 pressure volume loops with a combined pressure-conductance catheter (CD Leycom, Zoetermeer,
 the Netherlands). One criticism of this method is that acute hemodynamic measurements may not
 correlate to long term response. However, Delnoy et al demonstrated that acute improvements
 in LV function as measured by pressure-volume loops during implantation corresponded to
 clinical and echocardiographic improvement during follow-up. In addition, Duckett et al
 demonstrated that the acute dP/dt response to LV pacing is useful for predicting which
 patients are likely to remodel in response to CRT, for both dilated and ischemic
 cardiomyopathy.

 Despite these observations, few practitioners routinely utilize acute hemodynamic
 measurements for LV lead placement at the time of device implantation. Many practitioners
 believe targeted LV lead placement is impractical due to the time required to determine
 hemodynamic response to CRT and reposition the LV lead, and that venous anatomy, phrenic
 nerve pacing, and high pacing thresholds severely limit options for LV lead placement.

 Study Hypothesis

 It is hypothesized that it is both safe and feasible to use an interventional approach to LV
 lead placement (placing the LV lead guided by acute hemodynamic measurements), and that the
 LV lead can be placed in a position that is superior to the initial empiric lateral wall LV
 lead location in less than 30 minutes without significant risk to patients. The time from RV
 capture to LV activation correlates with the optimal pacing site based on stroke volume &
 dP/dt measurements.

 Study Purpose

 The purpose of this study is to determine whether utilizing the CD Leycom
 pressure-conductance catheter to measure dP/dt and pressure volume loops at the time of LV
 lead implant (whether for the initial CRT implant or revision of an existing system) is both
 safe and feasible. It is hoped that the study will determine whether it is possible to use a
 patient's hemodynamic response to pacing to locate an LV pacing site that provides better
 hemodynamic response to CRT than the empirically selected lateral wall pacing site without
 significant patient risk (in terms of radiation exposure, amount of contrast received,
 procedure time, potential injury).
Inclusion Criteria

 1. Ischemic or non-ischemic cardiomyopathy

 2. Patient meets all current criteria for CRT (NYHA Class III-IV heart failure, QRS ≥ 120
 ms, LVEF ≤ 35%, optimal medical therapy).

 3. Patient willing/able to sign study informed consent and HIPAA authorization.

 Exclusion Criteria

 1. Patient does not meet current criteria for CRT implant

 2. Mechanical aortic valve

 3. Left ventricular thrombus

 4. Aortic stenosis

 5. No palpable femoral pulse

 6. Extensive atherosclerotic disease of the aorta

 7. Serum creatinine > 2.5

 8. Patient not willing/able to sign study informed consent/HIPAA authorization.