TandemHeart Experiences and MEthods (THEME Registry)

This study is intended to be a multicenter, prospective observation registry. By collecting prospective descriptive data, provide insight into disease defining characteristics resulting in the clinical decision to use TandemHeart for mechanical support and enhance knowledge of best practice regarding clinical management, weaning and removal/exit strategies.

The TandemHeart percutaneous extracorporeal ventricular assist system is used to support circulation. The percutaneous cannulas facilitate access to the venous and arterial circulatory vessels. When connected to the TandemHeart centrifugal pump, mechanical support is provided with sufficient cardiac power to perfuse the organs of the body.

It is anticipated that THEME Registry analysis will provide insight into disease defining characteristics resulting in the clinical decision to use TandemHeart for mechanical support and enhance knowledge of best practice regarding clinical management, weaning and removal. The progression of the illness prior to, during and following TandemHeart support will be collected. The THEME Registry will collect descriptive data regarding patient selection criteria and the clinical management of the TandemHeart patient including strategies used to wean and remove the TandemHeart. Specifically the objectives of the THEME registry are:

• Summarize the characteristics of the patients who receive TandemHeart for temporary percutaneous mechanical support with or without an oxygenator, including demographics, pre-implant medical history, details of present illness, TandemHeart exit strategy.
• Evaluate the timing of initiation of TandemHeart mechanical support in relation to the progression of the presenting illness and the association of this with clinical outcomes.
• Collect descriptive data related to clinical management of the patient while on TandemHeart mechanical support, including procedural details, duration of support, anticoagulation, hemodynamics and biochemical parameters to define trends in clinical care and the association of this decision-making with clinical outcomes.
• Collect hospital discharge information including Intensive Care Unit (ICU) and Hospital length of stay (LOS).
• Collect survival and exit strategy status at 30 and 180 days post-initial TandemHeart insertion.
• Collect serious adverse events from the time of TandemHeart insertion through removal of the TandemHeart System (or TandemHeart Blood Pump).
• Provide data regarding TandemHeart case mix, patient characteristics, and outcomes.