Insertable cardiac monitor-guided early intervention to reduce atrial fibrillation burden following catheter ablation: Study design and clinical protocol (ICM-REDUCE-AF trial).

BACKGROUND: Percutaneous catheter ablation (CA) to achieve pulmonary vein isolation is an effective treatment for drug-refractory paroxysmal and persistent atrial fibrillation (AF). However, recurrence rates after a single AF ablation procedure remain elevated. Conventional management after CA ablation has mostly been based on clinical AF recurrence. However, continuous recordings with insertable cardiac monitors (ICMs) and patient-triggered mobile app transmissions post-CA can now be used to detect early recurrences of subclinical AF (SCAF). We hypothesize that early intervention following CA based on personalized ICM data can prevent the substrate progression that promotes the onset and maintenance of atrial arrhythmias. METHODS: This is a randomized, double-blind (to SCAF data), single-tertiary center clinical trial in which 120 patients with drug-refractory paroxysmal or persistent AF are planned to undergo CA with an ICM. Randomization will be to an intervention arm (n = 60) consisting of ICM-guided early intervention based on SCAF and patient-triggered mobile app transmissions versus a control arm (n = 60) consisting of a standard intervention protocol based on clinical AF recurrence validated by the ICM. Primary endpoint is AF burden, which will be assessed from ICMs at 15 months post-AF ablation. Secondary endpoints include healthcare utilization, functional capacity, and quality of life. CONCLUSION: We believe that ICM-guided early intervention will provide a novel, personalized approach to post-AF ablation management that will result in a significant reduction in AF burden, healthcare utilization, and improvements in functional capacity and quality of life.

Present and Future of Interventional Treatment of Resistant Hypertension.

The increasing prevalence of hypertension, a significant cause of disability and premature death throughout the world, is a major public health concern. This is especially true for the subset of patients who suffer from resistant hypertension, which is associated with a fourfold greater risk of cardiovascular events as compared to those hypertensive patients able to achieve target blood pressure. Though quite daunting in number and ill effect, hypertension remains the most common and the most important modifiable risk factor for coronary heart disease, congestive heart failure, peripheral vascular disease, stroke, and chronic kidney disease. Therefore, the ongoing development of novel therapies for the management of hypertension is of utmost importance. This review evaluates the present and future of interventional treatment of resistant hypertension, most of which remains investigational and warrants critical assessment.

Device-Directed Therapy for Resistant Hypertension.

Hypertension remains a significant risk factor for an array of diseases despite advancements in pharmacotherapy. Patients with resistant hypertension who do not respond to conventional medical treatments and lifestyle modifications are especially at risk for poor health outcomes. With the increasing awareness of resistant hypertension, ever-evolving research efforts continue to focus on innovative interventions, including renal denervation, median nerve stimulation, and baroreceptor activation therapy. This article reviews the current evidence and summarizes previous clinical trials for each of these interventions.