HRS 2019: Study shows no danger to CRM devices from airport body scans

Airport body scanners don’t appear to interfere with pacemakers and defibrillators, and noninvasive neurostimulation through the ear may help treat AFib. Those are but some of the insights coming out of the Heart Rhythm Society’s annual scientific sessions, held this week in San Francisco.

Here are some of the research highlights coming out of the conference:

Pacemaker and defibrillator patients shouldn’t worry about airport body scans

A new study out of Germany suggests that airport security body scanners don’t interfere with cardiac implantable electronic devices such as pacemakers or defibrillators. The study included 375 patients who underwent 1,000 body scans between May 2017 and October 2018. There were no events of electromagnetic interference recorded. “Our study results show that now patients can travel worry-free knowing they can safely go through security checkpoints without the need of disclosing personal medical information,” said the study’s lead author, lead author, Dr. Carsten Lennerz of the German Heart Centre Munich.

Bad news for Abbott and rotor-ablation AF

Abbott (NYSE:ABT) previously touted clinical studies showing the benefits of its technology involving focal impulse rotor modulation (FIRM) guided rotor ablation for treating atrial fibrillation. According to Abbott, FIRM-guided therapy allows physicians to identify and locate rotors — specific sources that sustain serious heart rhythm disorders — and tailor individualized treatment.

A team of international researchers, however, failed to find that FIRM plus conventional pulmonary vein isolation was superior to just PVI over a three- to 12-month period. Abbott sponsored the Reaffirm study. The prospective, multicenter, randomized, controlled trial involved 324 patients with persistent atrial fibrillation — 165 receiving FIRM therapy and 159 receiving conventional therapy.

Positive results for renal denervation

An international research team reported that renal artery denervation on top of pulmonary vein isolation significantly increased the likelihood of freedom from atrial fibrillation. Medical device companies including Medtronic and Biosense Webster provided consulting and research support for the Eradicate-AF trial, a single-blind randomized clinical trial involving about 300 patients at five centers. Researchers at the University of Rochester — along with colleagues in Russia, Poland and Germany — reported that 71.4% of the renal artery denervation plus pulmonary vein isolation group was free from AF after 12 months, versus 57.8% for the group only receiving PVI.

The results appear to be good news for Medtronic (NYSE:MDT), which continues to push forward with renal artery denervation technology as it seeks to clear up confounding factors from disappointing studies earlier in the decade.

Ear stim device could help treat AFib

University of Oklahoma researchers over a six-month period studied the effects of London-based Parasym‘s noninvasive neurostimulation device on roughly 50 paroxysmal AFib patients — half receiving vagus nerve stimulation through the external ear’s tragus and the other half receiving sham treatment on the ear lobe. After six months, the Parasym device reduced atrial fibrillation burden among patients actively using it by 85% compared to those receiving sham treatment. (Read more here.)

CVRx neurostim technology could help treat heart failure

A CVRx-sponsored study involving more than 400 patients suggests that the company’s baroreflex activation therapy (BAT) shows some promise treating heart failure. Six-month data from the BeAT-HF trial found significant improvement in the quality of life and exercise capacity among patients with heart failure with a reduced ejection fraction who received BAT and guideline-directed medical and device therapy (GMDT), versus the control group only receiving GMDT.

The research team — based in South Carolina, Tennessee, California, Minnesota, Ohio and France — is conducting the novel prospective two-phase randomized controlled trial as part of the FDA Breakthrough Devices Program.

Minneapolis-based CVRx has developed proprietary implantable technology for the treatment of high blood pressure and heart failure.

Patients with cardiac implantable electronic device need more education

A Cleveland Clinic study involving 344 patients with cardiac implantable electronic devices found many were unable to answer basic questions about their devices. The patients, who attended an in-person device evaluation at the Cleveland Clinic outpatient clinic between July and December 2018, filled out a one-page questionnaire with multiple choice questions covering type of CIED, original indication, functionality, manufacturer, number of active leads, estimated battery life, and number of shocks. Nearly two-thirds strongly agreed that they were knowledgeable about their device, but 84% of them missed at least one question. Nearly half missed at least two.