HRS 2015: Additional data supports SJM quadripolar cardiac resynchronization therapy system

May 18 2015

St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced the presentation of  important data around its SJM™ Quadra CRT System during the Heart Rhythm Society's (HRS) 36th annual scientific sessions. Multiple presentations showcase improved clinical outcomes, increased survival and better cost utilization with the St. Jude Medical quadripolar cardiac resynchronization therapy (CRT) system. Combined with a strong product pipeline, the growing body of clinical evidence supporting the SJM Quadra CRT System now includes more than 130 publications, further substantiating the company’s unique and comprehensive portfolio of heart failure management solutions.

A data presentation titled Incremental Survival Benefit of High Percent Biventricular Pacing in Quadripolar CRT was presented by Dr. Michael R. Gold, who led the study. The analysis looked at 8,973 patients with high and low percentages of biventricular (bi-v) pacing with the SJM Quadra CRT System, including the Quartet^™ LV Lead, compared to a standard bipolar pacing lead. High bi-v pacing was defined as resynchronization pacing rates equal to or greater than 93 percent. The mortality benefit of quadripolar leads was observed in both the high and low percentages of bi-v pacing patient groups. In patients with a high percentage of bi-v pacing, mortality was 24 percent lower in those with a Quartet LV lead than those with a conventional bipolar lead.

“The combination of high biventricular pacing with the Quartet LV lead shows an incremental survival benefit for patients already benefitting from the quadripolar pacing technology,” said Michael R. Gold, Chair of Cardiology from the Medical University of South Carolina. “Quadripolar pacing has become the standard of care and now we are seeing ways we can further improve our patients’ outcomes.”

Data presented during a session titled Quadripolar LV leads are Associated with Decreased Shock Burden in CRT-D Patients, by Dr. Mintu P. Turakhia, supports the findings from other studies that have demonstrated a shock reduction with quadripolar leads compared to bipolar leads and an improvement in survival for CRT-D patients. The analysis evaluated nearly 11,000 patients implanted with a CRT-D (8,640 with a quadripolar lead vs. 2,303 with a bipolar lead) found that the shock-free survival (chance of not getting an initial shock) was higher in patients implanted with the Quartet LV lead, showing a reduced risk of shocks by 13 percent compared to bipolar LV leads.

“This reduction in shock burden does not appear to be associated with device programming, rather it is most likely due to the benefits of the quadripolar lead technology,” said Mintu P. Turakhia, MD,  FHRS.

Additional data presentations for the St. Jude Medical quadripolar pacing system included Decreased Heart Failure Event Rates and associated Costs with Quadripolar versus Bipolar CRT-D systems, presented by Dr. Raffaele Corbisiero. These data showed that the Quartet LV lead exhibited a 31 percent reduction in post-implant heart failure hospitalization rates in the U.S. and a significant 39.8 percent reduction in associated costs compared to CRT-D patients with bipolar LV leads.

Quadripolar Pacing Technology from St. Jude Medical

St. Jude Medical introduced the industry’s first quadripolar CRT pacing system with the Quartet LV lead, featuring four uniquely spaced electrodes. The quadripolar CRT pacing system offers physicians the ability to effectively and efficiently manage the ever-changing needs of patients with heart failure. The system integrates multiple pacing configurations that enable physicians to optimize the system at implant and follow-up, as well as better manage common pacing complications without having to surgically reposition the lead.

St. Jude Medical’s Quartet lead design allows the physician to implant the lead in the most stable position without making trade-offs in electrical performance. This includes pacing closer to the base of the left ventricle, which studies associate with better patient outcomes and which may be more difficult with traditional bipolar leads. The quadripolar pacing electrodes also provide physicians more options to optimize CRT performance, such as pacing around scar tissue in the heart and avoiding the most common pacing complications.