Update on "Cell Therapy" Clinics Offering Treatments of Ocular Conditions Using Direct-To-Consumer Marketing Websites in the U.S.

Purpose: To assess the scope of U.S.-based companies advertising and administering non-Federal Drug Administration (FDA) approved cell-based therapy (herein called NFACT) for ocular conditions based on information from companies' public websites after the FDA's legal actions against specific NFACT clinics in 2018 and 2019.

Targeted Hypoglossal Nerve Stimulation for Patients With Obstructive Sleep Apnea: A Randomized Clinical Trial.

Importance: Evidence is lacking from randomized clinical trials of hypoglossal nerve stimulation in obstructive sleep apnea (OSA).

Objective: To evaluate the safety and effectiveness of targeted hypoglossal nerve stimulation (THN) of the proximal hypoglossal nerve in patients with OSA.

Design, Setting, And Participants: This randomized clinical trial (THN3) was conducted at 20 centers and included 138 patients with moderate to severe OSA with an apnea-hypopnea index (AHI) of 20 to 65 events per hour and body mass index (calculated as weight in kilograms divided by height in meters squared) of 35 or less.

Design and rationale for the treating Obstructive Sleep Apnea using Targeted Hypoglossal Nerve Stimulation (OSPREY) trial.

Obstructive sleep apnea (OSA) affects nearly 1 billion people worldwide, including approximately 35 million US residents. OSA has detrimental cardiovascular and neurocognitive consequences. Positive airway pressure corrects sleep disordered breathing but is not always tolerated or used sufficiently.

Auricular Vagus Neuromodulation-A Systematic Review on Quality of Evidence and Clinical Effects.

The auricular branch of the vagus nerve runs superficially, which makes it a favorable target for non-invasive stimulation techniques to modulate vagal activity. For this reason, there have been many early-stage clinical trials on a diverse range of conditions. These trials often report conflicting results for the same indication.

An exploratory propensity score matched comparison of second-generation and first-generation baroreflex activation therapy systems.

Baroreflex activation therapy (BAT) is a device-based therapy for patients with treatment-resistant hypertension. In a randomized, controlled trial, the first-generation system significantly reduced blood pressure (BP) versus sham. Although an open-label validation study of the second-generation system demonstrated similar BP reductions, controlled data are not presently available.

Surgical Experience and Long-term Results of Baroreflex Activation Therapy for Heart Failure With Reduced Ejection Fraction.

The purpose of this publication is to describe the intraoperative experience along with long-term safety and efficacy of the second-generation baroreflex activation therapy (BAT) system in patients with heart failure (HF) and reduced ejection fraction HF (HFrEF). In a randomized trial of New York Heart Association Class III HFrEF, 140 patients were assigned 1:1 to receive BAT plus medical therapy or medical therapy alone. Procedural information along with safety and efficacy data were collected and analyzed over 12 months.

Effects of chronic carotid baroreceptor activation on arterial stiffness in severe heart failure.

Background: Heart failure with reduced ejection fraction (HFrEF) is characterized by activation of the sympathetic nervous system and increased arterial stiffness, leading to an impaired ventricular-vascular coupling. Baroreflex activation therapy (BAT) has been shown to reduce muscle sympathetic nerve activity (MSNA) and improve clinical status of patients with HFrEF. The purpose of this investigation was to determine the effects of BAT on arterial stiffness in HFrEF.

Long-term chronic baroreflex activation: persistent efficacy in patients with heart failure and reduced ejection fraction.

Aims: Baroreflex activation therapy (BAT) has recently been shown to reduce muscle sympathetic nerve activity and hospitalization rate while improving clinical variables through 6 months of therapy in patients with heart failure and reduced ejection fraction (HFrEF). The objective of the present study is to extend the information on this patient cohort over a long-term follow-up.

Methods And Results: Eleven patients were enrolled in the study and presented with optimized, stable medical therapy, New York Heart Association Class III HFrEF with left ventricular ejection fraction 40% or less, impaired functional capacity and no active cardiac resynchronization therapy.

Baroreflex activation therapy for the treatment of heart failure with a reduced ejection fraction: safety and efficacy in patients with and without cardiac resynchronization therapy.

Aims: Increased sympathetic and decreased parasympathetic activity contribute to heart failure (HF) symptoms and disease progression. Carotid baroreceptor stimulation (baroreflex activation therapy, BAT) results in centrally mediated reduction of sympathetic and increase in parasympathetic activity. Because patients treated with cardiac resynchronization therapy (CRT) may have less sympathetic/parasympathetic imbalance, we hypothesized that there would be differences in the response to BAT in patients with CRT vs.

Baroreflex Activation Therapy for the Treatment of Heart Failure With a Reduced Ejection Fraction.

Objectives: The objective of this clinical trial was to assess the safety and efficacy of carotid BAT in advanced HF.

Background: Increased sympathetic and decreased parasympathetic activity contribute to heart failure (HF) symptoms and disease progression. Baroreflex activation therapy (BAT) results in centrally mediated reduction of sympathetic outflow and increased parasympathetic activity.

Bilateral or unilateral stimulation for baroreflex activation therapy.

Unlabelled: Previous trials have shown that in patients with resistant hypertension device-based baroreflex activation therapy (BAT) can substantially reduce blood pressure. However, the fact that electrodes had to be implanted bilaterally may be a drawback for further development of the technique. In this study, we explored whether unilateral stimulation would produce comparable results as bilateral stimulation.

Chronic baroreflex activation effects on sympathetic nerve traffic, baroreflex function, and cardiac haemodynamics in heart failure: a proof-of-concept study.

Aims: Heart failure (HF) pathophysiology is believed to be mediated by autonomic dysfunction, including chronic sympathoexcitation and diminished baroreflex sensitivity, which correlate with mortality risk. Baroreflex activation therapy (BAT) is a device-based treatment providing chronic baroreflex activation through electrical stimulation of the carotid sinus. BAT chronically reduces sympathetic activity in resistant hypertension.

Striking improvement in a case of reduced ejection fraction heart failure with baroreflex activation therapy.

A patient experiencing chronic New York Heart Association (NYHA) Class III heart failure with reduced left ventricular ejection fraction and signs of right ventricular dysfunction is treated with baroreflex activation therapy (BAT). Despite optimal medical therapy, the patient had repeatedly decompensated and was approaching a refractory terminal stage. BAT chronically reduced muscle sympathetic nerve activity and dramatically improved clinical presentation of the patient to NYHA Class I through 12 months of therapy.

The baroreceptor as a therapeutic target for heart failure.

Sympathoactivation is a prominent feature of heart failure (HF). Its role in cardiac remodeling and arrhythmogenesis is well-recognized today, although incomplete understanding of autonomic mechanisms was a barrier to development of contemporary medical therapies. Despite widespread availability of drugs and devices, mortality and morbidity in HF remain unacceptably high.

Cost-effectiveness of Barostim therapy for the treatment of resistant hypertension in European settings.

Objective: The purpose of this study is to simulate the cost-effectiveness and the long-term clinical performance of the Barostim neo System for the treatment of resistant hypertension when compared to optimal medical treatment.

Methods: A decision analytic model with a combination of a decision tree and Markov process was used to evaluate the cost-effectiveness of Barostim. The clinical effectiveness of Barostim was based on the results of the randomized, placebo-controlled Rheos trial and the follow-up substudy of the DEBuT-HT trial.

Minimally invasive system for baroreflex activation therapy chronically lowers blood pressure with pacemaker-like safety profile: results from the Barostim neo trial.

Background: Previous trials have demonstrated clinically significant and durable reductions in arterial pressure from baroreflex activation therapy (BAT), resulting from electrical stimulation of the carotid sinus using a novel implantable device. A second-generation system for delivering BAT, the Barostim neo™ system, has been designed to deliver BAT with a simpler device and implant procedure.

Methods: BAT, delivered with the advanced system, was evaluated in a single-arm, open-label study of patients with resistant hypertension, defined as resting systolic blood pressure (SBP) ≥140 mm Hg despite treatment with ≥3 medications, including ≥1 diuretic.

Baroreflex activation therapy provides durable benefit in patients with resistant hypertension: results of long-term follow-up in the Rheos Pivotal Trial.

The objective of this study was to assess long-term blood pressure control in resistant hypertension patients receiving baroreflex activation therapy (BAT). Following completion of the randomized Rheos Pivotal Trial, patients participated in open-label, nonrandomized follow-up to assess safety and efficacy of BAT. Blood pressure reductions were measured relative to a pre-implant baseline as well as the results achieved at the completion of 1 year of follow-up in the randomized phase.

Effects of electrical stimulation of the carotid sinus baroreflex using the Rheos device on ventricular-vascular coupling and myocardial efficiency assessed by pressure-volume relations in non-vagotomized anesthetized dogs.

We investigated the effects of the carotid sinus baroreflex on coupling of the left ventricle (LV) and the arterial system in twelve anesthetized dogs, with all nerves and carotid sinus circulation intact and instrumented to measure LV pressure and volume. The Rheos(R) device was used to directly electrically stimulate the carotid sinus baroreceptors. Stimulation resulted in a significant reduction in systolic blood pressure (SBP), 95.

Chronic baroreflex activation by the Rheos system: an overview of results from European and North American feasibility studies.

The baroreflex, whose role is well-known in short-term blood pressure regulation, has until recently been unexploited as a practical therapy for hypertension. Recent advancements in approach and technology embodied in the Rheos System have enabled chronic electrical activation of the baroreflex. Chronic results from feasibility studies indicate that Rheos Therapy has an acceptable safety profile and may lead to long-term control of pressure in drug-resistant hypertension patients.

Advanced rhythm discrimination for implantable cardioverter defibrillators using electrogram vector timing and correlation.

Introduction: Discrimination of ventricular and supraventricular arrhythmias remains one of the major challenges for appropriate implantable defibrillator (ICD) therapy delivery. The electrogram vector timing and correlation (VTC) algorithm was developed for such rhythm discrimination. The VTC algorithm differentiates normally conducted supraventricular beats from abnormally conducted ventricular beats by comparing the timing and correlation of rate and shock channel electrograms.