Journal of Innovation in Cardiac Rhythm Management
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Six Late-Breaking Clinical Trials Presented at HRS

The results of six late-breaking clinical trials presented on Thursday included an assessment of the impact of remote monitoring, the safety and efficacy of wireless LV endocardial stimulation for CRT, and injection of botulinum toxin to prevent AF after cardiac surgery. The most recent results from the VENTURE-AF, FREEZE-AF, and EVERA MRI studies were also presented.

Randomized and observational data have shown that remote monitoring (RM) improves patient survival. However, it is unknown whether RM reduces healthcare utilization (HCU). Jonathan P. Piccini, MD, of Duke University Medical Center, presented the results of a study in which he and his colleagues investigated whether RM was associated with reduced all-cause clinical events and HC costs. The researchers used a large, real-world cohort from MarketScan® Commercial and Medicare Supplemental (MS) claims databases.

“We found, for patients on a regular follow-up regimen, that remote monitoring is associated with reduced HCU, irrespective of device type,” Piccini said. “On average, utilization of RM avoids 8.9 hospitalizations, 70.6 hospital days, and saves $196,800 per 100 patient-years. Since fewer than half of patients routinely utilize RM, this represents a major opportunity for quality improvement.”

Determinants of RM adoption (patient and physician factors) and mediators between RM use and HCU require further elucidation, he noted.

Vivek Y. Reddy, MD, of Mount Sinai School of Medicine in New York, presented the results of the SELECT-LV study demonstrating the feasibility of direct, wireless endocardial LV pacing to achieve CRT. SELECT-LV is a non-randomized, six-center study of CRT-indicated patients with either a failure of conventional CRT, or requiring an upgrade but unsuitable for conventional CRT.

“Some patients do not benefit from conventional CRT because of lead issues, such as an inability to place the CS lead or lack of clinical improvement with CRT,” Reddy said. “Left ventricle endocardial pacing has been proposed as a potential solution.”

To explore this, the researchers assessed the safety and performance of the novel Wireless Cardiac Stimulation System (WiCS-LV) to provide endocardial LV stimulation.

“Ultimately, what I think this study shows is that left-ventricular pacing is possible and it appears to confer significant benefits,” Reddy said. “However, we need to confirm this in a larger number of patients to determine how safe it can be.”

A pilot study conducted by investigators in Russia and the U.S. sought to compare the efficacy and safety of botulinum toxin injection into epicardial fat pads for preventing atrial tachyarrhythmias in patients with paroxysmal AF undergoing coronary artery bypass graft (CABG) surgery.

Evgeny Pokushalov, MD, PhD, of the State Research Institute of Circulation Pathology in Novosibirsk, Russia, presented the study’s findings, which suggest that botulinum toxin injection into epicardial fat pads during CABG provided substantial atrial tachyarrhythmia suppression, both early and at one-year follow-up, without any serious adverse events.

Michael R. Gold, MD, PhD, FHRS, of the Medical University of South Carolina, presented the latest results of the EVERA MRI study, a multicenter, randomized evaluation of patients with de novo eligibility for an implantable cardioverter-defibrillator.

“MRI of conventional implantable cardioverter-defibrillators is contraindicated due to potential patient risks of MRI,” Gold said. “In this study, we evaluated the safety and efficacy of an ICD system specially designed for full-body MRI without restrictions on heart rate or pacing dependency.”

Based on their findings, Gold and his colleagues concluded the system is safe and that the MRI scan does not adversely affect the electrical performance or treatment of ventricular arrhythmias of the ICD system.

There are only a few studies comparing pulmonary vein isolation (PVI) using open irrigated radiofrequency (RF) energy ablation versus the cryoballoon (Cryo) ablation for patients with paroxysmal atrial fibrillation (PAF).

The FREEZE-AF study, conducted by researchers at the University of Heidelberg in Germany, is the first large prospective, randomized controlled, non-inferiority study comparing the effectiveness and safety of the Cryo versus RF energy for PVI in patients with PAF. In their analysis of 315 patients with PAF, the investigators reported that procedure success rates for the intention-to-treat population at six months and 12 months were similar, demonstrating the non-inferiority of the Cryo ablation versus RF ablation in patients with PAF.

Researchers representing the multi-national VENTURE-AF trial reported the latest findings of this study, which suggest that uninterrupted rivaroxaban appears to be a safe alternative to vitamin K antagonists in patients undergoing catheter ablation for nonvalvular atrial fibrillation.