The Pipeline

TCT 2012: Interventional heart failure devices of the future

Haley David

The Pipeline reports on the heart failure (HF) community's groundbreaking research and future technology presented by leading interventional cardiologists at the 2012 Transcatheter Cardiovascular Therapeutics conference.

Physician leaders sought to answer this question: Is interventional heart failure the next big breakthrough? Presenters and panelists posed provocative questions about middle to late stage heart failure treatment and new devices in development stages.

Presentations covered the following major topics:

  • Novel device-based therapies for advanced heart failure
  • Chronic indwelling pressure monitoring
  • Stem cell therapies for myocardial repair

Emerging interventional devices could close historic gap in heart failure treatment

The first presentation given by Dr. Daniel Burkoff was entitled “Novel Device-Based Therapies for Advanced Heart Failure." Dr. Burkoff began by describing the HF treatment gap in late NYHA Class III to early Class IV patients.

Within Class III treatment, new CRT devices, gene/cell therapy, renal denervation (RDN), and mitral valve repair all play critical roles in patient care. Class IV treatment has historically been defined by transplants and LVADs.

These treatments have yet to find a convergence point. With innovative HF interventions emerging, however, there is clear opportunity to address this historic gap in Class III to IV HF treatment. Three device groups demonstrating potential to narrow this gap include:

1. Parachute Device (Cardiokinetix)

The Parachute™ device is indicated for HF patients after myocardial infarction. The device works by partitioning the non-functioning tissue from the functional which offers left ventricular support to increase blood flow.

The device is implanted at the apex and inflates into the base of the left ventricle. The procedure takes approximately 75 minutes within a traditional cath lab setting. The device was CE marked in October 2012 and has been implanted in 88 patients. A U.S. pivotal trial is currently underway.

2. Inter-Atrial Shunt Device

The Inter-Atrial Shunt Device provides left atrial pressure relief for HF patients. The device is placed between the left and right atrium to alleviate pressure, particularly during exertion. In first-in-man studies conducted outside the U.S., the device has shown the ability to create a well-controlled shunt between the right and left atria, improving exercise capacity and enhancing quality of life (QOL).

The Inter-Atrial Shunt Device has potential to demonstrate pronounced improvements in exercise tolerance in moderate to late-stage HF patients, an essential QOL measure for these patients.

3. Miniaturized LVAD (the CircuLite Synergy Micro-Pump LVAD)

VADs have become the mark of comprehensive HF programs nationwide, especially for hospitals who seek to differentiate themselves without expansion into transplants. Current continuous-flow VAD technology has recently evolved tremendously with the emergence of Thoratec's HeartMate II and HeartWare HVAD (pending FDA approval).

These devices serve patients with the most advanced HF, and there are few options for less acute patients. Dr. Burkoff addressed this deficit directly  by presenting on miniaturized LVADs, which may open the traditional devices up to a much broader patient population.  Most notable among them, the CircuLite® Synergy® Micro-Pump LVAD offers ventricular support through a minimally-invasive procedure, including a mini-thoracotomy for inflow cannula placement and a small pocket for subclavian access and micro-pump insertion.

Synergy's Micro-Pump is the size of a double A battery and provides up to 4.25 liters of blood flow per minute. With its reduced size, Synergy minimizes risks associated with fully open surgical procedures and may offer improvements to patient length of stay, follow-up care, and overall quality of life.

Implantable left atrial pressure sensors a paradigm shift in HF monitoring

The interventional HF session also evaluated technology options for new HF monitoring, labeling implantable hemodynamic monitors a paradigm shift in HF care. Panelists speculated that weight monitoring may not be as valuable as it has been perceived.

Instead, true atrial pressure monitoring, like that offered by the CardioMEMS and the Patient Advisor Module (PAM) by St. Jude Medical, may provide a more accurate depiction of HF decompensation. Specifically, the CardioMEMS device has demonstrated a 28% relative risk reduction in HF hospitalizations.

St. Jude’s LAPTOP-HF trial, which is currently underway, compares left atrial pressure (LAP) monitors with physician-directed prescriptions based on PAM module readings to traditional medication reminders. With continued emphasis on alternate sites of services for HF patients and decreased HF readmissions, these devices may play a pivotal role in enhancing the HF care continuum.

Stem cells: HF treatment of the future?

Stem cell therapy for cardiac remodeling represents the possible future of HF treatment. Using predominantly bone marrow-derived stem cells, researchers have demonstrated improved cardiac remodeling.

While replacing cardiac muscle seems extraordinarily far-reaching, the ability for repetitive stem cell therapy to slow or hinder HF progression may be possible.

More information on the 2012 TCT conference

Join us for a webconference on Nov. 27 for a comprehensive overview of the latest research and technological developments presented by industry experts at the 2012 TCT conference. Register now.