This article is more than 5 years old. Information may no longer be current.
New technologies to treat arrhythmias unveiled at HRS
Click Here to Manage Email Alerts
BOSTON —Data relating to numerous new technologies providing new solutions for patients with arrhythmia disorders were unveiled at the Heart Rhythm Society Annual Scientific Sessions.
Among the technologies featured were an algorithm to promote atrioventricular synchronous pacing with a ventricular leadless pacemaker, an extravascular implantable cardioverter defibrillator lead, an intramural needle ablation technology to treat refractory ventricular arrhythmias, a system providing multi-electrode contact mapping plus ablation to treat atrial fibrillation and a novel single-chamber ICD that can detect asymptomatic atrial arrhythmias.
Leadless pacemaker algorithm
The MARVEL study tested an algorithm developed for the ventricular leadless pacemaker (Micra, Medtronic) to help patients who require atrioventricular synchronous pacing.
“These patients were getting the benefits of a leadless pacemaker by the substantially lower complications, but they were not benefiting from atrioventricular synchrony, meaning their atrium was working, but this was a ventricular pacemaker alone,” Larry A. Chinitz, MD, FHRS, Alvin Benjamin and Kenneth Coyle, Sr. Family Professor of Medicine and Cardiac Electrophysiology and director of the Cardiac Electrophysiology and Heart Rhythm Center at NYU Langone Health, said during a press conference. “There is substantial value from [atrioventricular] synchrony, such as improvement in cardiac output, functional status, quality of life and loss of pacemaker syndrome. The question became, can the accelerometer that exists within the leadless pacemaker sense the acceleration of blood flow related to atrial contraction without there being a lead in the atrium?”
Chinitz and colleagues downloaded the algorithm into 70 patients with an existing ventricular leadless pacemaker; there were 64 usable Holter readings (mean age, 72 years; 31% women) for the study.
The mean atrioventricular synchrony rate was 87% (95% CI, 81.8-90.9; range, 30.2-100), and 83% of patients had an atrioventricular synchrony rate greater than 70%, Chinitz said.
“In the patients with [atrioventricular] block, we were able to achieve [atrioventricular] synchrony greater than 80% of the time,” Chinitz said during the press conference. “Complications were extraordinarily minimal. In patients with intact conduction, the presence of the algorithm did not interfere with their normal function. We also found that when patients increased their activity, there was a higher loss of [atrioventricular] synchrony because the signals within the heart get pushed together. However, at higher heart rates, most cardiac output is dependent on rate and not [atrioventricular] synchrony, so from a clinical perspective, we do not think the lower performance at higher heart rates will matter.”
Extravascular ICD lead
For the ASD2 study, Lucas V.A. Boersma, MD, PhD, from St. Antonius Hospital Nieuwegein, the Netherlands, and colleagues evaluated the feasibility of sensing, pacing and defibrillation from a novel acutely implanted lead (Medtronic) designed for the substernal space.
“This is a new way of defibrillating the heart,” Boersma said during the press conference. “Instead of doing it from inside the heart, we did it by putting the lead under the sternum. There are many issues with ICD leads and there is a need to do something else aside from putting them in the vascular space.”
The subcutaneous ICD also addresses this problem, but cannot provide pacing, which the novel lead under the sternum close to the heart is able to do, he said.
The lead was placed in 79 patients (mean age, 62 years; 86% men), of whom 52 had transvenous ICD placement or replacement, 11 had subcutaneous ICD placement or replacement, 15 had cardiothoracic surgery and one had a patent foramen ovale closure.
Ventricular pacing capture success was 76% in the ring-ring vector, 77% in the ring-coil vector and 97% in the coil-coil vector, Boersma said during the press conference.
Single 30-J shock success was 81% in the first episode, 86% in those with a second episode tested and 83% for all episodes together, he said.
There were seven adverse events in six patients, most of which were resolved without sequelae, he said.
Intramural needle ablation technology
An arrhythmia substrate that goes deep below the endocardium is a significant cause of ablation failure, so deep intramural radiofrequency lesions may be required. William G. Stevenson, MD, professor of medicine at Vanderbilt University Medical Center and a member of the Cardiology Today Editorial Board, assessed the safety and efficacy of a novel irrigated needle catheter for mapping and ablation of ventricular arrhythmias that failed standard catheter ablation and antiarrhythmic drug therapy.
“When ablation is needed for a ventricular tachycardia that originates from deep within the myocardium, beneath the endocardial surface, you may not be able to adequately damage the VT region with available technologies,” Stevenson, the co-inventor of the technology, said during the press conference. “In multicenter trials for ablation of VT, recurrence rates are in the range of 30% to 50%. We now have a catheter with a 27-gauge needle that can be extended out through the catheter and driven into the myocardium. The needle is then irrigated with saline and radiofrequency current applied on the needle. This makes a deep intramural lesion.”
Median procedure time was 287 minutes and median fluoroscopy time was 32 minutes.
At 6 months, 68% of patients had no or less ventricular tachycardia and 32% had continued ventricular tachycardia, Stevenson said. Likewise, 68% of patients were receiving fewer antiarrhythmic drugs at discharge.
“Of the 31 patients, 49% had no recurrent VT whatsoever, and considering that this is a population who had failed prior ablation attempts and often had electrical storms or required IV medications, that was gratifying,” Stevenson said. “This is an indication that this ablation method can be helpful in the right patients.”
Eighteen percent of procedures had complications, most typical of catheter procedures and unrelated to needle ablation, he said.
Mapping and ablation system
Researchers tested a novel catheter (Globe Mapping and Ablation System, Kardium) among 60 patients with AF (mean age, 64 years) in the GLOBAL-AF study.
“One of the most critical questions is whether we can develop a new catheter that can combine all the options of a single-tip catheter with the easy use of a balloon catheter,” Hans Kottkamp, MD, from the department of electrophysiology at Hirslanden Hospital, Zurich, said during the press conference. “This catheter has 122 electrodes and multiple mapping options, so it is both an ablation and mapping catheter.”
The technology achieved pulmonary vein isolation in 99.2% of veins. Mean procedure time was 147 minutes and mean fluoroscopy time was 11 minutes. Two patients had tamponade, one of which occurred before ablation, and there were no cases of stroke, transient ischemic attack, pulmonary vein stenosis, esophageal perforation or phrenic nerve palsy, Kottkamp said.
Thirty-nine patients were treated with a single “hot shot,” and of those, 85% had no AF recurrence or use of antiarrhythmic drugs at 6 months, he said.
“We obtained results in our very first clinical series with the Globe catheter that are already comparable with results from established technologies (single-tip and cryoballoon) after 20 years of their development — implicating that we expect to have superior results with the Globe very soon after some additional development of the Globe technology,” Kottkamp told Cardiology Today.
Single-chamber ICD
Brian Powell, MD , FACC, FHRS , medical director for cardiac electrophysiology at Sanger Heart & Vascular Institute, Atrium Health, and Amy Tucker, RN, advanced cardiac device nurse at Sanger, evaluated the ability of a single-chamber ICD with atrial sensing capabilities (VR-T DX ICD System, Biotronik) to determine the incidence of asymptomatic AF or other undiagnosed atrial arrhythmias in 152 patients (72% men) implanted with the ICD between May 2013 and August 2017.
During the study period, 30% of patients had confirmed AF/atrial tachycardia detections, 4% had AF detections due to noise on the atrial channel, 14% of patients had AF events despite being asymptomatic and having no history of AF events and 4% had supraventricular tachycardia with no prior history documented, Powell said during a presentation.
Fourteen of the asymptomatic patients with AF were indicated for anticoagulation based on CHA2DS2-VASc score, but two were deferred because of fall or bleeding risk, he said.
The device had a sensitivity of 100% and a specificity of 96.64% for detection of events in the ventricular tachycardia/ventricular fibrillation zone, he said, noting that some undersensing was observed, which could mean atrial arrhythmia incidence was higher than reported.
“This novel single-chamber ICD with atrial sensing capabilities detected atrial fibrillation that did not fall into any [ventricular tachycardia] detection zone,” Powell said during the presentation. “Larger studies will be needed to determine if this unique lead technology could reduce the risk of stroke by initiation of anticoagulation when asymptomatic AF is detected.” – by Erik Swain
References:
Boersma LVA, et al. LBCT03-03.
Chinitz LA, et al. LBCT03-04.
Kottkamp H, et al. LBCT03-02.
Stevenson WG, et al. LBCT03-01.
Tucker AG, et al. Abstract B-AB26-04. All presented at: Heart Rhythm Society Annual Scientific Sessions; May 9-12, 2018; Boston.
Disclosures: The ASD2 and MARVEL studies were funded by Medtronic. The GLOBAL-AF study was funded by Kardium. Boersma reports he received compensation for services from Abbott, Boston Scientific and Medtronic, received research grants from Medtronic and received fellowship support from Boston Scientific. Chinitz reports he received compensation for services from Abbott, Biosense Webster, Biotronik, Medtronic and Pfizer and fellowship support from Biotronik, Boston Scientific and Medtronic. Kottkamp reports he consults for Biosense Webster and Kardium and holds equity in Kardium. Powell reports he consults for Biotronik, Boston Scientific, Medtronic and St. Jude Medical. Stevenson reports he received compensation for services from Abbott and Boston Scientific and holds intellectual property rights for a product made by Biosense Webster.