Talking points included in this deck are for internal/speaker use only, and are not to be distributed.

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2 Talking points included in this deck are for internal/speaker use only, and are not to be distributed. Before presenting the CHAMPION study, I would like to provide a brief overview of the CardioMEMS HF System. The design and function of each component will be discussed in detail later in the presentation and demonstrated during the breakout session this afternoon. The CardioMEMS HF System consists of the PA sensor, Hospital & Patient Electronics, and the PA Pressure Website. 2

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5 Talking points included in this deck are for internal/speaker use only, and are not to be distributed. If we look at he physiologic markers that are used today to manage HF patients they occur late in the time course of decompensation and provide little time to react before a hospitalization these include weight, symptoms and BP. In order to successfully manage HF patients and impact the time course of decompensation you need to identify the issue before the patient becomes symptomatic and congested. Since increases in filling pressures cause decompensation monitoring pressure changes will assist in identifying presymptomatic congestion in order to allow time to react and alter the time course of decompensation Graph adapted from: Adamson PB. Pathophysiology of the transition from chronic compensated and acute decompensated heart failure: new insights from continuous monitoring devices. Curr Heart Fail Rep Dec;6(4):

6 Talking points included in this deck are for internal/speaker use only, and are not to be distributed. The acute HF syndrome that leads to worsening HF is a complex process and begins with increases in pressure the start the cycle. 6

7 Talking points included in this deck are for internal/speaker use only, and are not to be distributed. High rates of HF-related hospitalizations may further contribute to the progression of heart failure and LV dysfunction. With each admission for acute heart failure syndromes, there may be a short-term improvement. However, the patient often leaves with a further decrease in cardiac function. Graph adapted from: Gheorghiade MD, et al. Pathophysiologic targets in the early phase of acute heart failure syndromes. Am J Cardiol. 2005; 96[suppl]: 11G-17G. 7

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9 Talking points included in this deck are for internal/speaker use only, and are not to be distributed. This graphical representation of cumulative heart failure hospitalizations illustrates that the primary efficacy outcome at 6 months was met and its durability over the full study duration (average of 15 months) is maintained. This shows an apparent improvement in efficacy over prolonged follow-up (with a RRR of 37%), rather than any indication that there is a loss of treatment effect. 9

10 Talking points included in this deck are for internal/speaker use only, and are not to be distributed. The only pre specified sub group analysis was HF hospitalizations by baseline ejection fraction. A reduction in HF hospitalizations was observed in both the reduced EF patients (24% reduction) and preserved EF patients (46% reduction). The finding of reduction in HF hospitalizations in the preserved EF group is important, as no previous trial has proven effective in this group. 10

11 Talking points included in this deck are for internal/speaker use only, and are not to be distributed. The only pre specified sub group analysis was HF hospitalizations by baseline ejection fraction. A reduction in HF hospitalizations was observed in both the reduced EF patients (24% reduction) and preserved EF patients (46% reduction). The finding of reduction in HF hospitalizations in the preserved EF group is important, as no previous trial has proven effective in this group. 11

12 Talking points included in this deck are for internal/speaker use only, and are not to be distributed. This retrospective analysis looked at HFrEF patients in the Champion Clinical Trial already on guideline-directed medical therapy (GDMT). In 337 patients in this analysis there were 163 in the treatment group and 174 in the control group. Management with PA pressure (treatment group) showed a 43% reduction in HF hospitalizations and 57% reduction in mortality. This reduction in HF hospitalization and improvement in survival was over and above the benefits of neurohormonal control through PAP management. This data supports the mortality trend observed in the Champion Clinical Trial (Abraham, et al Lancet, 2011). In addition it is in line with studies that have shown the relationship between HF hospitalizations and mortality where HF hospitalizations are a strong predictor of mortality (Lee DS, et al. Am J of Med, 2009 and Setoguchi S, et al. Am Heart J, 2007 ). 12

13 Talking points included in this deck are for internal/speaker use only, and are not to be distributed. This retrospective analysis looked at HFrEF patients in the Champion Clinical Trial already on guideline-directed medical therapy (GDMT). In 337 patients in this analysis there were 163 in the treatment group and 174 in the control group. Management with PA pressure (treatment group) showed a 43% reduction in HF hospitalizations and 57% reduction in mortality. This reduction in HF hospitalization and improvement in survival was over and above the benefits of neurohormonal control through PAP management. This data supports the mortality trend observed in the Champion Clinical Trial (Abraham, et al Lancet, 2011). In addition it is in line with studies that have shown the relationship between HF hospitalizations and mortality where HF hospitalizations are a strong predictor of mortality (Lee DS, et al. Am J of Med, 2009 and Setoguchi S, et al. Am Heart J, 2007 ). 13

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