St. Jude Medical, Inc. is touting results from a large-scale, clinical study concluding that the St. Jude Medical Quartet™ left-ventricular (LV) quadripolar lead provides more options to effectively manage common pacing complications compared to systems with bipolar leads.
Background
Failed implant rates in heart failure (HF) patients receiving a cardiac resynchronization therapy (CRT) system are high with bipolar LV pacing leads due to anatomy (creating lead stability problems), phrenic nerve stimulation (PNS) or poor electrical measurements. Quadripolar systems should theoretically reduce the risk of complication considerably, and so it seems is the case in this newly presented study.
Results from the MORE-CRT study were presented during a hot line late-breaking session at the European Society of Cardiology Congress 2014 (ESC 2014). The study title is a true test of the acronymtastic study tag, derived from “More Options available with a quadripolar LV lead pRovidE in clinic solutions to CRT challenges.”
More than 60 centers from 13 countries participated in this first randomized, large-scale clinical study of more than 1,000 patients comparing the St. Jude Medical Quartet lead to bipolar LV leads (one-third of bipolar leads were St. Jude Medical and two-thirds were non-St. Jude Medical). The primary endpoint of the study was freedom from intra- and post-operative LV lead-related events at six months.
Results showed that complications occurred less frequently and were managed more efficiently in patients who received the Quartet lead than in patients who received bipolar electrode leads.
The Quartet lead was associated with a statistically significant increase in freedom from combined LV lead-related events — 85.97 percent in patients implanted with a Quartet lead compared to 76.86 percent in patients implanted with a bipolar LV lead.
Investigator comments
“The risk of LV lead-related events was more than 40 percent lower in patients implanted with a Quartet CRT-D system relative to patients implanted with a bipolar CRT-D system,” said Prof. Giuseppe Boriani, M.D., Ph.D., of the Institute of Cardiology, University of Bologna, Italy, and the MORE-CRT steering committee chairman. “The overall freedom from intraoperative and post-operative LV lead-related events was significantly higher in quadripolar CRT group versus bipolar CRT group. These data are very important in deciding how we treat our patients going forward.”
Company comments
“The design of St. Jude Medical’s Quartet quadripolar technology is unique,” said Dr. Mark D. Carlson, chief medical officer and vice president of global clinical affairs for St. Jude Medical. “The MORE-CRT study confirms that our quadripolar system has set the standard for the quadripolar pacing industry and the study is a strong addition to the more than 100 publications showing our technology improves outcomes and quality while reducing costs.”
Source: St. Jude Medical, Inc., Business Wire
