Profile of St. Jude Medical’s Allure Quadra quadripolar pacemaker system for cardiac resynchronization therapy

Abstract

Congestive heart failure is a major public health epidemic and economic burden in the USA and worldwide. Cardiac resynchronization therapy is an effective therapy for treating congestive heart failure in conjunction with pharmacologic therapy. The average congestive heart failure admission costs approximately US$ 8 billion annually. Current cardiac resynchronization therapy pacemaker systems from various manufacturers deliver therapy-utilizing bipolar leads including the left ventricle, with electrode spacing ranging from 8 to 22 mm. The Quartet LV™ lead model 1458Q (St. Jude Medical Sylmar, CA) is a quadripolar lead with a 4.0 Fr. tip electrode and three 4.7 Fr. ring electrodes located 20, 30 and 47 mm from the tip. The Quartet lead and Allure Quadra TM allows 14 pacing configurations, providing benefits, including reductions in phrenic nerve stimulation, reduced pacing thresholds, improved battery longevity and potential reductions, in non-responders to cardiac resynchronization therapy. In addition, there is cost benefit data from utilizing quadripolar technology compared with traditional bipolar cardiac resynchronization therapy.

Keywords:

• biventricular pacing
• cardiac pacing
• cardiac resynchronization pacemaker
• congestive heart failure
• quadripolar leads

Financial & competing interests disclosure

R Corbisiero has received speaking honoraria from Boston Scientific and St. Jude Medical. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Key issues

• Cardiac resynchronization therapy (CRT) with or without defibrillation backup has been associated with positive outcomes when combined with optimal pharmacologic therapy decreasing symptoms, hospitalizations, while increasing survival and some reverse remodeling of left ventricular function in most patients.

• Improvement can still be achieved over traditional bipolar CRT systems as 20–40% of patients implanted receive marginal or no benefit from this therapy.

• Increased patient populations suffering from congestive heart failure and associated costs for treatment of congestive heart failure will continue to rise and burden health care systems internationally.

• Left ventricular pacing via the coronary sinus utilizing bipolar leads limits not only the number of stimulation options available but also the area of electrode separation to only 8–22 mm. This limits current systems in overcoming anatomic obstacles, such as phrenic nerve stimulation, high capture thresholds and optimal positioning due to vessel size and stability.

• The Allure Quadra CRTP allows 14 specific left ventricular stimulation options between the pulse generator and Quadripolar left ventricle (LV) lead. In addition, the lead provides electrode separation of 47 mm and has demonstrated reductions in revisions due to anatomic obstacles, including phrenic nerve stimulation, elevated thresholds and dislodgements.

• The Allure Quadra CRTP provides novel intraventricular conduction measurements that may provide additional methods of device optimization in addition to other options in managing patients post-implant to reduce non-responder rates to CRT therapy. This includes utilizing sites of stimulation otherwise unavailable due to vessel size and lead stability trade-offs at the time of implantation.

• Economic data in favor of Qudripolar LV pacing over bipolar LV pacing is beginning to emerge, demonstrating reductions in healthcare utilization and hospitalization rates with quadripolar technology. Downstreaming costs, including lower rates invasive revisions, options for optimizing in conjunction with remodeling or changes to LV function.

• The expansion capabilities of this system available in electrode stimulation timing, electrode spacing, and options for altering current therapies that are producing sub-optimal responses will allow for a robust area for research and better patient management options and outcomes.