Stimulus Intensity in Left Ventricular Leads and Response to Cardiac Resynchronization Therapy

BACKGROUND: Increased left ventricular (LV) stimulus intensity has been shown to improve conduction velocity and cardiac output. However, high-output pacing would shorten device battery life. Our prospective trial analyzed the clinical effects of high- versus low-output LV pacing. METHODS AND RESULTS: Thirty-nine patients undergoing initial cardiac resynchronization therapy device implantation with bipolar LV leads were assigned to 3 months of either high-output LV pacing (Hi) or low-output LV pacing (Lo) in a randomized, blinded crossover fashion. Hi and Lo settings were determined with a rigorous intraoperative protocol specific to each patient. Clinical and echocardiographic data were obtained at randomization, at 3 months, and a subsequent 3 months after crossover. Mean age was 66.4±9.8 years, and mean QRS duration was 159.3±23.1 ms. Compared to baseline, both arms had significant improvements in Minnesota Living With Heart Failure score (given as mean [95% confidence interval]) (baseline versus Lo: 43.3 [35.5 to 51.1] versus 21.3 [14.6 to 28.0], P<0.01; baseline versus Hi: 43.3 [35.5 to 51.1] versus 23.6 [16.1 to 31.1], P<0.01) and 6-minute walk distance (baseline versus Lo: 692 ft [581 to 804] versus 995 ft [876 to 1114], P<0.01; baseline versus Hi: 699 ft [585 to 813] versus 982 ft [857 to 1106], P<0.01). Although both Hi and Lo arms had some echocardiographic parameters that significantly improved compared to baseline (baseline end-diastolic diameter 5.7 cm [5.5 to 6.0] versus Lo 5.5 cm [5.1 to 5.8], P<0.01; baseline end-systolic diameter 4.9 cm [4.6 to 5.3] versus Hi 4.7 cm [4.3 to 5.0], P<0.05), there were no significant differences observed when comparing the Hi- versus Lo-output arms. CONCLUSIONS: Low-output LV pacing with a relatively narrow safety margin above capture threshold affords significant improvement from baseline and is clinically equivalent to high-output LV pacing. These data support a strategy of minimizing the programmed LV safety margin to increase battery life in cardiac resynchronization therapy devices. CLINICAL TRIAL REGISTRATION INFORMATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01060449.