Table 6 Summary of extended PICO to define research question that assessment will investigate Patients Intervention Comparator Outcomes to be assessed Healthcare resources to be considered Patient must meet Cardiac Failed Peak VO2 Insertion, removal or all of the following contractility optimal Improvement in replacement of CCM IPG device criteria: modulation medical quality of life Insertion, removal or (a) Symptomatic therapy + therapy (MLWHF) replacement of the bipolar leads heart failure due to OMT (OMT) Improvement in NYHA CCM IPG device systolic left classification; and LVEF Device costs ventricular Mean change in 6 Bipolar leads dysfunction despite minute hall walk test Anaesthesia failed Optimal All-cause mortality and Cardiologist Medical Therapy; all-cause Cardiac monitoring (b) NYHA Class III hospitalisations. Hospital stay (c) ≥ 18 years; Death or Ongoing interrogation of device (d) Normal QRS hospitalisation due to Prophylactic antibiotics duration (<120ms); HF Cardiologist visit (e) LVEF ≥25% Device and GP visits ≤45% related side effects Outpatient visits Serious adverse events Heart Failure medications Incremental cost per Management of adverse life year saved events/complications Incremental cost per Outpatient visits QALY gain Emergency service Outcomes for the economic model may include: Primary Efficacy Outcomes QALY Overall survival Safety Outcomes Adverse Events Lead Failure An example of a decision analytic model is provided below. There are no published cost effectiveness models available for CCM although published economic evaluations exist for CHF. A model will be prepared for the MSAC application. Figure 7: Indicative decision diagram for cost effectiveness model
Table 6 Summary of extended PICO to define research question that assessment will investigate Patients Intervention Comparator Outcomes to be assessed Healthcare resources to be considered Patient must meet all of the following criteria: (a) Symptomatic heart failure due to systolic left ventricular dysfunction despite failed Optimal Medical Therapy; (b) NYHA Class III (c) ≥ 18 years; (d) Normal QRS duration (<120ms); (e) LVEF ≥25% ≤45% Cardiac contractility modulation therapy + OMT Failed optimal medical therapy (OMT) Peak VO2 Improvement in quality of life (MLWHF) Improvement in NYHA classification; and LVEF Mean change in 6 minute hall walk test All-cause mortality and all-cause hospitalisations. Death or hospitalisation due to HF Device and side effects Serious adverse events Incremental cost per life year saved Incremental cost per QALY gain Insertion, removal or replacement of CCM IPG device Insertion, removal or replacement of the bipolar leads CCM IPG device Device related costs Bipolar leads Anaesthesia Cardiologist Cardiac monitoring Hospital stay Ongoing interrogation of device Prophylactic antibiotics Cardiologist visit GP visits Outpatient visits Heart Failure medications Management of adverse events/complications Outpatient visits Emergency service Outcomes for the economic model may include: Primary Efficacy Outcomes QALY Overall survival Safety Outcomes Adverse Events Lead Failure An example of a decision analytic model is provided below. There are no published cost effectiveness models available for CCM although published economic evaluations exist for CHF. A model will be prepared for the MSAC application. Figure 7: Indicative decision diagram for cost effectiveness model
1387-FinalProtocol.docx