Medtronic 's Tiny Pacemaker Is Now FDA Approved for AV Block

The device touted as the world's smallest pacemaker is now FDA approved for patients with AV block, a condition in which the electrical signals between the chambers of the heart are impaired. FDA approved the original Micra Transcatheter Pacing System in 2016 for patients with atrial fibrillation or other dangerous arrhythmias such as bradycardia-tachycardia syndrome. The Micra AV is identical in size and shape to the original device, but has several additional internal sensing algorithms which detect cardiac movement, allowing the device to adjust pacing in the ventricle to coordinate with the atrium, providing "AV synchronous" pacing therapy to patients with AV block. The Micra AV approval was based on data from the MARVEL 2 (Micra Atrial Tracking Using A Ventricular accELerometer) study, which evaluated the safety and effectiveness of accelerometer-based atrial sensing algorithms. The study evaluated the ability of the Micra’s internal sensor to monitor and detect atrial contractions and enable coordinated pacing between the atrium and ventricle, thereby providing AV synchrony. Results from the study, presented in November at the American Heart Association 2019 Scientific Sessions and published simultaneously in the Journal of the American College of Cardiology: Clinical Electrophysiology, showed the primary efficacy objective was met, with a significantly greater percentage of complete heart block patients wi...
Source: MDDI - Category: Medical Devices Authors: Tags: Implants Source Type: news

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Abstract BACKGROUND: Ryanodine receptor (RyR) dysfunction in skeletal muscle (RyR1) leads to malignant hyperthermia, and in cardiac muscle (RyR2) triggers cardiac arrhythmias. We hypothesized that RyR dysfunction in vascular smooth muscle could increase vascular resistance and hypertension, and may contribute to increased atrial fibrillation (AF) in hypertension. Thus, stabilizing RyR function with chronic dantrolene treatment may attenuate hypertension and AF inducibility in spontaneously hypertensive rats (SHR). METHODS: Male SHR (16 weeks-old) were randomized into vehicle- (n=10) and dantrolene-treated (10...
Source: American Journal of Hypertension - Category: Cardiology Authors: Tags: Am J Hypertens Source Type: research
Conditions:   Paroxysmal Atrial Fibrillation;   Persistent Atrial Fibrillation Interventions:   Device: Cryoballoon ablation;   Device: Radiofrequency ablation Sponsors:   Karan Saraf;   University of Manchester Not yet recruiting
Source: ClinicalTrials.gov - Category: Research Source Type: clinical trials
CONCLUSIONS: Sustained parasympathetic denervation during 12 months after CPVI was a marker of successful CPVI, whereas a 3-month post-CPVI SDNN reduction (ΔSDNN(post-CA[3 m])) of ≤ 25 ms predicted LRAF occurrence. PMID: 32049070 [PubMed - as supplied by publisher]
Source: Polish Heart Journal - Category: Cardiology Authors: Tags: Kardiol Pol Source Type: research
CONCLUSIONS: There was significantly less recurrence of atrial arrhythmias at 12 months after PVI with VGLB. A negative APT after PVI with VGBL predicted freedom from AF with a very high NPV meaning that the high acute efficiency of the VGLB persisted long term. PMID: 32023574 [PubMed - as supplied by publisher]
Source: Circulation Journal - Category: Cardiology Authors: Tags: Circ J Source Type: research
Michel Mirowski and his colleagues gave the field of implantable cardioverter-defibrillators (ICDs) a pretty good start, but what's more impressive is how far the technology has advanced since that first human ICD implant in February 1980. In the past 40 years we've seen ICDs become dramatically smaller, longer lasting, more capable, more personalized, subcutaneous (non-transvenous), and even MRI-firendly. And that's not to mention the advanced data connectivity and monitoring capabilities that the latest technologies offer. So without further ado, let's take a look at the current ICD landscape and the companie...
Source: MDDI - Category: Medical Devices Authors: Tags: Implants Source Type: news
ConclusionDurable lesions could be obtained after linear ablation with the CB for the LAPW roof line, especially in those with a relatively short LAPW roof line. However, patients requiring touch ‐up ablation with radiofrequency were included, and that was associated with a potential financial implication.This article is protected by copyright. All rights reserved.
Source: Journal of Cardiovascular Electrophysiology - Category: Cardiology Authors: Tags: ORIGINAL ARTICLE Source Type: research
AbstractIn adults with congenital heart disease, atrial fibrillation occurs at a  lower age due to the increased atrial stress compared to structurally normal hearts. The ablation target thus results from the underlying heart defect and the specific arrhythmia: in the case of atrial fibrillation, pulmonary vein isolation with left atrial substrate modification can be performed safely and effectively taking into account the individual cardiac lesion, which is often related to difficult transseptal access. This case is a representative example of catheter ablation of atrial fibrillation in a patient with a&nbs...
Source: Herzschrittmachertherapie und Elektrophysiologie - Category: Cardiology Source Type: research
This study is an extremely important step in assessing the Amplatzer Amulet as an effective non-prescription drug alternative for patients with AFib who are at an increased risk for ischemic stroke." In an email sent to MD+DI, Abbott wrote, “We already have an Amulet IDE trial underway that is intended to support our submission for approval in the U.S. for Amplatzer Amulet. The newly announced CATALYST trial will support our submission for an expanded indication for Amulet as a safe and effective alternative to NOAC drugs for patients with atrial fibrillation and at risk of stroke.”...
Source: MDDI - Category: Medical Devices Authors: Tags: Cardiovascular Regulatory and Compliance Source Type: news
Aims Atrial fibrillation is the most common sustained arrhythmia in the general population, and circumferential pulmonary vein isolation has emerged as a cornerstone in the treatment of drug-resistant atrial fibrillation. However, there is a paucity of data regarding the CHA2DS2-VASc and SAMe-TT2R2 scores as predictors of outcomes among patients with nonvalvular atrial fibrillation on vitamin K antagonists after radiofrequency catheter ablation (RFCA). Methods The current prospective observational study enrolled 304 consecutive patients with atrial fibrillation who underwent RFCA. Warfarin was maintained for at least ...
Source: Journal of Cardiovascular Medicine - Category: Cardiology Tags: Research articles: Arrhythmias Source Type: research
This study aimed to clarify whether the DF of surface ECG in patients with persistent AF could predict arrhythmia recurrence after catheter ablation. We investigated 125 patients with persistent AF who underwent catheter ablation between January 2009 and December 2016. Thirty-four patients (27%) had arrhythmia recurrence after catheter ablation. These patients showed a significantly high DF value in leads aVL (7.2  ± 0.7 Hz vs 6.6 ± 0.9 Hz,p 
Source: Heart and Vessels - Category: Cardiology Source Type: research
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