Investigator-Initiated Research

Key Areas of Interest for Investigator Initiated Research

Neuromodulation

1. Early vs Late use of VNS in DRE: Retrospective analyses evaluating clinical outcomes and healthcare utilization in patients with DRE receiving early (for example: within 5 years of DRE onset) versus late (including post-resection) intervention with VNS Therapy.

2. Optimization of VNS settings: Case series of optimization of VNS settings and titration schedules on seizure control and adverse event profile with a special interest in pediatric outcomes.

3. Comorbidities: Case series and retrospective studies evaluating changes in mood, depression, and/or cognition using validated instruments in patients with DRE treated with VNS Therapy.

4. VNS response prediction: Proof of concept studies utilizing biomarkers of response to VNS. Response includes identifying ideal candidates for VNS, predicting seizure response, QoL response, or improvement in comorbidities. 

5. Exploratory indications: Case series and retrospective studies exploring additional benefits of VNS Therapy.

General Considerations

• Analysis of existing patient databases that have been systematically collected as part of an ongoing evidence generation program are highly desirable (for example The Epilepsy Learning Healthcare System (ELHS), pELHS (pediatric Epilepsy Learning Healthcare System), and International Consortium for Health Outcomes Measurement (ICHOM)).

• Clinical outcomes of interest: seizure frequency, seizure severity, mortality, injury, quality of life (both disease specific and generic health status measures such as EQ5D), depression, cognition, loss of function, and failure to achieve developmental milestones (validated assessments preferred).

• Patient Reported Outcome Measures (PROMs) measuring the patients’ views of their health status are welcomed.

• Inclusion of Patient Reported Experience Measures (PREMs) measuring the patients’ perceptions of their experience are encouraged.

• Societal impact outcomes of interest include education, employment, productivity and socio-economic impact of DRE on caregivers and patients.

• Investigator Initiated Research that evaluates the use of a device that is not in accordance with the approved labeling requires prior approval from the relevant Competent Authority. See LivaNova’s Physician Manual and product labeling for a full listing of Indications, Contraindications, Warning and Precautions. 

Advanced Circulatory Support

1. Studies that quantify the outcomes of RA-PA Dual Lumen Cannulation with oxygenation in patients with acute respiratory failure. Clinical and economic outcomes to quantify and compare the efficacy and safety of ProtekDuo vs conventional veno-veno cannulation. Clinical outcomes including early ambulation, RV function, mechanical ventilation dependency, ability to connect or disconnect the oxygenator without interruption of support, ICU length of stay, total length of stay, recovery time, hospital costs, staff dependency, complications, and mortality are of interest. Economic analyses may include cost effectiveness analyses, cost consequence analyses, and budget impact models.

2. Studies that compare VA-ECMO using LifeSPARC to other temporary percutaneous heart pumps in patients with acute cardiac insufficiency. Clinical and economic outcomes to quantify and compare the efficacy, safety, and healthcare utilization for patients treated with LifeSPARC compared to other heart pumps. Clinical outcomes including time to ambulation, blood product use, central venous pressure, recovery time, ICU length of stay, total length of stay, hemodynamic parameters, complications, and mortality are of interest. Economic analyses may include cost effectiveness analyses, cost consequence analyses, and budget impact models.

3. Usability studies that evaluate the implementation of an ECMO program utilizing LifeSPARC. Usability and clinical outcomes to quantify and compare the ease of use of the ECMO program using LifeSPARC. Outcomes including set up time, rapid initiation, number of FTE required to implement the program, staff dependence (total cost of support staff). Key interests include the correlation of rapid initiation and with clinical and economic outcomes, number of staff to manage the device and patient post insertion, cost savings compared to conventional programs.

Cardiopulmonary

1. Demonstrate the impact of Goal-Directed perfusion protocols using predictive and/or advanced CPB monitoring technologies on reducing adverse outcomes, such as: acute kidney injury (AKI) or postoperative cognitive dysfunction (POCD)

2. Establish benefit of goal-directed perfusion as a key element of ERAS (Enhanced Recovery) Pathways as evidenced by impact on clinical & economic outcomes. 

3. Demonstrate benefits of Essenz Perfusion System Data management and workflow strategies utilizing Goal-Directed perfusion and Quality Indicators for multi-center, national or international benchmarking on pre, peri and post procedural patient characteristics and outcomes. 

4. Demonstrate how Essenz sensors accuracy (e.g. ILBM) could impact the quality of goal-directed perfusion in comparison to other available options on the market.