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European Heart Rhythm Association Issues Very Interesting Report on New Devices for the Treatment of Heart Failure

Implantable devices for the treatment of heart failure, David Prutchi, PhD

 

A position paper was published yesterday by the European Heart Rhythm Association reporting on the performance of new devices for the treatment of heart failure (HF). The report has been endorsed by the Heart Failure Association.

The abstract for the paper titled “New devices in heart failure: an European Heart Rhythm Association report” reads:

 Several new devices for the treatment of heart failure (HF) patients have been introduced and are increasingly used in clinical practice or are under clinical evaluation in either observational and/or randomized clinical trials. These devices include cardiac contractility modulation, spinal cord stimulation, carotid sinus nerve stimulation, cervical vagal stimulation, intracardiac atrioventricular nodal vagal stimulation, and implantable hemodynamic monitoring devices. This task force believes that an overview on these technologies is important. Special focus is given to patients with HF New York Heart Association Classes III and IV and narrow QRS complex, who represent the largest group in HF compared with patients with wide QRS complex. An overview on potential device options in addition to optimal medical therapy will be helpful for all physicians treating HF patients.

The report places special focus to patients with HF New York Heart Association (NYHA) Classes III and IV and narrow QRS complex, who represent the largest group in HF compared with patients with wide QRS complex (who are candidates for treatment with cardiac resynchronization therapy – CRT).

The paper stresses that it is especially important to evaluate new device-based therapies because results of a recent study showed that patients with mechanical dyssynchrony detected by Doppler imaging but a normal QRS duration did not benefit from CRT. Although CRT is indicated in patients with a prolonged QRS duration, up to 60% of patients with HF have a normal QRS duration. According to European registries published recently, even in the broad QRS population, those cared in hospital cardiology setting and meeting the current indications to CRT therapy were 6%, and among them approximately one-third only were actually implanted with a CRT device. Therefore, although the last ESC guidelines on HF extended the indications to CRT in chronic heart failure, a substantial proportion of patients remain either not eligible for CRT or simply do not respond.  In contrast, some of these new therapies, for example Impulse Dynamics’ Cardiac Contractility Modulation have shown significant improvement in all (NYHA) Classes III and IV patient populations.  The paper also points out that data for randomized clinical trials are available only for the Impulse Dynamics Optimizer device among these new AIMDs intended for the treatment of HF.

The report is authored by the top European authorities in Heart Failure:  Karl-Heinz Kuck (Chairperson, Germany), Pierre Bordachar (France), Martin Borggrefe (Germany), Giuseppe Boriani (Italy), Haran Burri (Switzerland), Fancisco Leyva (UK), Patrick Schauerte (Germany), Dominic Theuns (The Netherlands), and Bernard Thibault (Canada).  The report was reviewed by: Paulus Kirchhof (Review Coordinator, UK), Gerhard Hasenfuss (Germany), Kenneth Dickstein (Norway), Christophe Leclercq (France), Cecilia Linde (Sweden), Luigi Tavazzi (Italy), and Frank Ruschitzka (Switzerland).

The report presents the concept, mechanism of action, and clinical results of the following devices and technologies:

  • Cardiac Contractility Modulation (Impulse Dynamics’ Optimizer)
  • Spinal Cord Stimulation
  • Carotid Sinus Nerve Stimulation
  • Cervical Vagal Nerve Stimulation (BioControl, CVRx)
  • Intracardiac AV-nodal Vagal Stimulation
  • RV-Pressure Monitoring
  • LA-Pressure Monitoring (Heart-POD)
  • Pulmonary Artery Pressure(CardioMEMS)

The report is a must-read for professionals interested in AIMDs for the treatment of heart failure!

IMPORTANT NOTE: Please note that although I am employed by Impulse Dynamics, the purpose of this blog is in no way to promote or advertise the companies for which I work.  As such, for any and all inquiries regarding Impulse Dynamics or its products, please contact Impulse Dynamics directly through its webpage at: www.impulse-dynamics.com

CAUTION – The OPTIMIZER IVs System is not currently available in the USA.  The Optimizer III System is an INVESTIGATIONAL DEVICE, LIMITED BY FEDERAL (OR UNITED STATES) LAW TO INVESTIGATIONAL USE.  PLEASE READ FULL DISCLAIMER ON SIDE COLUMN AND IN THE LEGAL SECTION OF THIS WEBSITE.

 

 

 
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