Boston Scientific’s Minnesota-based cardiac device division is touting new clinical data on its latest heart-mapping technology, which uses an onion-shaped probe festooned with sensors to measure electrical signals at tens of thousands of discrete points inside the heart.
Heart-rhythm problems like atrial fibrillation often stem from bad connections in the heart’s natural electrical system, and one common treatment, called ablation, involves deliberately severing electrical connections in the heart muscle. Several medical-device companies make machines that can map the heart for ablation procedures, but they vary in resolution and speed.
New data show that Boston Scientific’s Rhythmia Mapping System, when used with the company’s Intellamap Orion Mapping Catheter, can improve the chances of a successful procedure by giving electrophysiologists a way to create a real-time map of the heart with thousands of datapoints in just minutes, before and after an ablation procedure.
Data presented this week at the European Heart Rhythm Association meeting in Barcelona, Spain, show that use of the Intellamap Orion probe’s “ultrahigh density” mapping system led to successful treatments in 80 percent of the 108 atrial fibrillation patients it was used on; overall, success rates for six different heart arrhythmias varied from 64 percent to 96 percent, according to data from the observational, non-randomized True-HD study.
Company officials noted that in half of the 504 cases in the study, doctors used the system to create a second map to validate whether their initial ablations had severed the bad connections; 73 percent of the time, the system showed a need for additional ablations in newly identified areas to complete the procedure. Without that ability, patients might have to wait for symptoms and return to the hospital for another ablation.
“The better a job you do at the first procedure, obviously, the less likely it will be that you’ll need to come back to have a repeat procedure,” said Dr. Ken Stein, chief medical officer for rhythm management and global health policy at Boston Scientific. “That is great for patients. Also, when you look at the economics of value-based health care, that can be critical” for health care providers.
The study had what investigators called a “very low rate” of adverse events possibly related to the mapping catheter, including two cases in which patients’ pre-existing pacemaker leads came dislodged.
The key to the accurate mapping is in the Intellamap Orion probe, which is threaded into the heart from a small incision in a blood vessel near the groin. The device is studded with 64 electrodes that can quickly create a live, high-definition map of how electrical signals flow through heart tissue. Older versions of mapping catheters have fewer sensors, leading to slower and less-accurate images.
For the 504 patients in the True-HD study, doctors usually created at least two maps per patient, with a median of 6,983 points of data per map, according to the data presented in Barcelona. The median time to acquire one map was about nine minutes.
“A simple [heart] chamber, people find they can map in as little as five minutes. For a more complex chamber, a more complex arrhythmia, typically it’s on the order of 10 to 15 minutes of mapping,” Stein said.