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SENSE: Single-lead system performs similarly to dual-chamber ICDs
A novel implantable cardioverter defibrillator system without an atrial lead was similar to dual-chamber ICDs and superior to single-chamber ICDs at detecting atrial high-rate episodes, according to the results of the SENSE trial.
Researchers evaluated the novel ICD system (DX, Biotronik), single-chamber ICDs and dual-chamber ICDs for ability to diagnose subclinical atrial fibrillation by detecting atrial high-rate episodes, which are associated with thromboembolism. The DX system, which has a single lead and does not require an atrial sensing lead, can be used in ICDs and cardiac resynchronization therapy defibrillators, according to a press release from Biotronik.
“The DX ICD system is capable of detecting subclinical AF as well as a dual-chamber ICD system and better than a single-chamber ICD system,” George Thomas, MD, electrophysiologist at NewYork Presbyterian Hospital/Weill Cornell Medicine, told Healio. “Also, the DX system performed with very good stability of atrial sensing and ICD function.”
For the study, Thomas and colleagues implanted the DX system in 150 patients with no known history of AF who required an ICD (mean age, 59 years; 72% men), and compared them with patients matched by age, sex and left ventricular ejection fraction who were implanted with a single-chamber ICD at Cornell or who were implanted with a dual-chamber ICD in the IMPACT trial.
The primary outcome was detection of atrial high-rate episodes at 12 months.
During the study period, atrial-high rate episodes were detected more often in the DX group compared with the single-chamber ICD group (13% vs. 5%; P = .026) and similarly in the DX group compared with the dual-chamber ICD group (13% vs. 13%), according to the researchers.
Among patients in the DX cohort, none had inappropriate therapy delivered and 3% had sensed atrial amplitudes less than 1 mV, Thomas and colleagues wrote.
“The DX ICD system could be used for patients receiving ICDs who do not have an atrial pacing indication and are at risk for subclinical AF,” Thomas said in an interview. “The ongoing DX-AF study is also randomizing patients between a standard VVI single-lead system and a VDD single-lead system to assess subclinical AF detection in a cohort of 378 patients.” – by Erik Swain
For more information:
George Thomas, MD, can be reached at Division of Cardiology, Cornell University Medical Center, 525 E. 68th St., Starr 4, New York, NY 10021; email: get2007@med.cornell.edu.
Disclosure: The trial was sponsored by Weill Medical College of Cornell University in conjunction with Biotronik. Thomas reports he receives research grants from and consults for Biotronik and consults for Medtronic. Please see the study for all other authors’ relevant financial disclosures.