Mapping system safe, effective in arrhythmia procedures

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Use of a mapping system and mapping catheter was safe and effective in a variety of procedures to treat arrhythmias, according to results from the TRUE-HD registry.

Researchers analyzed 572 patients at 27 global sites, of whom 519 underwent a procedure with the mapping system (Rhythmia, Boston Scientific) and mapping catheter (IntellaMap Orion, Boston Scientific) and were eligible for catheter ablation with a mapping procedure of any arrhythmia excluding de novo atrial fibrillation. There were 504 patients who had a completed mapping procedure, and they were followed for 1 month after the procedure. Gerhard Hindricks, MD, head of the electrophysiology department at Leipzig University Heart Center in Germany, presented the findings at EHRA 2018.

“In most patients with substrate-based cardiac arrhythmias, electrophysiologic information about the properties of the substrate is key for the development of an appropriate treatment strategy,” Hindricks told Cardiology Today. “Currently, substrate-based arrhythmias constitute approximately 75% of all indications in interventional electrophysiology. This technology focuses on the key challenges in interventional and curative treatment of cardiac arrhythmias. However, until the TRUE-HD study was completed, large-scale, multicenter data with more solid information on the mapping ability and properties, safety aspect and outcome, workflow and process effects had not been available.”

The primary endpoint was acute procedural success, defined as assessing ability to map an arrhythmia or its substrate, completion of the necessary ablation applications, arrhythmia termination where applicable and validation through appropriate techniques. The researchers also compiled device-related adverse events, including serious adverse events.

During the study period, 61 events in 49 patients were documented, of which 4% were ablation-related complications and 0.57% were related to the mapping catheter, the researchers reported.

“Overall, the TRUE-HD study proved for the first time in the frame of a multicenter, prospective, controlled trial that utilization of the mapping platform in patients with complex cardiac arrhythmias is safe,” Hindricks said in an interview.

Among the cohort, 83.3% had a successful procedure confirmed by arrhythmia-specific validation techniques (95% CI, 79.8-86.5). Success rates were 96% for cavotricuspid isthmus-dependent atrial flutter, 83% for non-cavotricuspid isthmus-dependent macro re-entrance atrial tachycardia, 81% for non-macro re-entrance atrial tachycardia, 80% for AF, 64% for ventricular arrhythmias and 94% for other arrhythmias.

“Of note, these were in patients with complex cardiac arrhythmias, where you generally do not achieve procedural success approaching 100%,” Hindricks said. “The clinical application of the system is very efficient.”

Median time per procedure for maps acquisition was 29 minutes, 41 seconds (interquartile range, 16:15-49:08), according to the researchers.

Among patients who had maps collected for validation purposes, 73% required additional ablation after validation mapping, according to the researchers.

“This is significant for the individual patient, as it may lead to less recurrences and less redo procedures,” Hindricks said. – by Erik Swain


Reference:

Hindricks G, et al. Late-breaking science: registries. Presented at: EHRA 2018; March 18-20, 2018; Barcelona, Spain.


Disclosure: The study was funded by Boston Scientific. Hindricks reports his institution receives research grants from Abbott, Biosense Webster, Boston Scientific and Medtronic.

Use of a mapping system and mapping catheter was safe and effective in a variety of procedures to treat arrhythmias, according to results from the TRUE-HD registry.

Researchers analyzed 572 patients at 27 global sites, of whom 519 underwent a procedure with the mapping system (Rhythmia, Boston Scientific) and mapping catheter (IntellaMap Orion, Boston Scientific) and were eligible for catheter ablation with a mapping procedure of any arrhythmia excluding de novo atrial fibrillation. There were 504 patients who had a completed mapping procedure, and they were followed for 1 month after the procedure. Gerhard Hindricks, MD, head of the electrophysiology department at Leipzig University Heart Center in Germany, presented the findings at EHRA 2018.

“In most patients with substrate-based cardiac arrhythmias, electrophysiologic information about the properties of the substrate is key for the development of an appropriate treatment strategy,” Hindricks told Cardiology Today. “Currently, substrate-based arrhythmias constitute approximately 75% of all indications in interventional electrophysiology. This technology focuses on the key challenges in interventional and curative treatment of cardiac arrhythmias. However, until the TRUE-HD study was completed, large-scale, multicenter data with more solid information on the mapping ability and properties, safety aspect and outcome, workflow and process effects had not been available.”

The primary endpoint was acute procedural success, defined as assessing ability to map an arrhythmia or its substrate, completion of the necessary ablation applications, arrhythmia termination where applicable and validation through appropriate techniques. The researchers also compiled device-related adverse events, including serious adverse events.

During the study period, 61 events in 49 patients were documented, of which 4% were ablation-related complications and 0.57% were related to the mapping catheter, the researchers reported.

“Overall, the TRUE-HD study proved for the first time in the frame of a multicenter, prospective, controlled trial that utilization of the mapping platform in patients with complex cardiac arrhythmias is safe,” Hindricks said in an interview.

Among the cohort, 83.3% had a successful procedure confirmed by arrhythmia-specific validation techniques (95% CI, 79.8-86.5). Success rates were 96% for cavotricuspid isthmus-dependent atrial flutter, 83% for non-cavotricuspid isthmus-dependent macro re-entrance atrial tachycardia, 81% for non-macro re-entrance atrial tachycardia, 80% for AF, 64% for ventricular arrhythmias and 94% for other arrhythmias.

“Of note, these were in patients with complex cardiac arrhythmias, where you generally do not achieve procedural success approaching 100%,” Hindricks said. “The clinical application of the system is very efficient.”

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Median time per procedure for maps acquisition was 29 minutes, 41 seconds (interquartile range, 16:15-49:08), according to the researchers.

Among patients who had maps collected for validation purposes, 73% required additional ablation after validation mapping, according to the researchers.

“This is significant for the individual patient, as it may lead to less recurrences and less redo procedures,” Hindricks said. – by Erik Swain


Reference:

Hindricks G, et al. Late-breaking science: registries. Presented at: EHRA 2018; March 18-20, 2018; Barcelona, Spain.


Disclosure: The study was funded by Boston Scientific. Hindricks reports his institution receives research grants from Abbott, Biosense Webster, Boston Scientific and Medtronic.



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