Haran Burri discusses the remote monitoring of cardiac resynchronisation therapy, the ACUITY X4 multipolar leads and the outcomes of the RALLY-X4 study.
FILMED AT THE CARDIOSTIM ANNUAL MEETING, JUNE 2016
WHAT ARE THE ADVANTAGES OF THE ACUITY X4 MULTIPOLAR LEADS?
00:10 – So these are quadripolar leads that allow us to more easily position them in the coronary sinus veins. They also give us more options to reduce the pacing thresholds, the captured thresholds. And finally, to avoid pacing the phrenic nerve.
WHAT HAVE BEEN THE OUTCOMES OF THE RALLY-X4 STUDY?
00:33 – So, this was actually the first phase which we’re presenting here at CardioStim, the post-marketing clinical follow-up in the first 201 patients. And what we found was that the success for delivery of CRT at three months was present in all but one of the 201 patients, that’s to say, in over 99% of patients who received CRT delivery at three months. And in fact the electrical measurements were very good, with on average about 1 volt captured thresholds and very good stability. We had no cases that needed to be re-operated for early dislodgement. There was one case that needed repositioning due to persistent phrenic nerve capture.
WHY IS REMOTE MONITORING OF CRT NEEDED?
01:28 – It’s becoming the standard of care now for these patients. These patients have high incidences of clinical issues, arrhythmias, be it atrial arrhythmias or ventricular arrhythmias that could benefit from being monitored and diagnosed early on. They also have more heart failure events. So, we can monitor various parameters for heart failure. And finally, these patients are also at a somewhat higher risk for technical issues, that’s to say, for instance, high left ventricular threshold. And these are things that we can actually monitor using remote monitoring and act upon them more quickly.
WHAT ARE THE LIMITATIONS OF THE REMOTE MONITORING OF CRT DEVICES?
02:14 – So, the limitations are data overload because these devices can upload quite a lot of data off the patients to the hospitals, and the hospital staff are faced with a lot of data overload. So, what could work around this are integrated diagnostics where you have automatic algorithms that look at different parameters and risk stratify patients into higher risk, medium risk and lower risk, meaning that the hospital staff can focus on those patients who are at higher risk—that’s about 10% of the patients—and then deal specifically with those 10% of patients.