Heart rhythm : the official journal of the Heart Rhythm Society
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Multicenter Study
Clinical safety of the ProMRI pacemaker system in patients subjected to head and lower lumbar 1.5-T magnetic resonance imaging scanning conditions.
Permanent cardiac pacemakers have historically been considered a contraindication to magnetic resonance imaging (MRI). ⋯ The results of the ProMRI/ProMRI AFFIRM studies demonstrate the clinical safety and efficacy of the ProMRI pacemaker system in patients subjected to head and lower lumbar MRI conditions.
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Randomized Controlled Trial Multicenter Study
Low inappropriate shock rates in patients with single- and dual/triple-chamber implantable cardioverter-defibrillators using a novel suite of detection algorithms: PainFree SST trial primary results.
The benefits of implantable cardioverter-defibrillators (ICDs) have been well demonstrated in many clinical trials, and ICD shocks for ventricular tachyarrhythmias save lives. However, inappropriate and unnecessary shock delivery remains a significant clinical issue with considerable consequences for patients and the healthcare system. ⋯ In a large patient cohort receiving ICDs for primary or secondary prevention, the adoption of novel enhanced detection algorithms in conjunction with routine implementation of modern programming strategies led to a very low inappropriate shock rate.
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Randomized Controlled Trial Multicenter Study
MRI scanning in patients with new and existing CapSureFix Novus 5076 pacemaker leads: randomized trial results.
Magnetic resonance imaging (MRI) can be safely performed in patients with magnetic resonance (MR)-conditional pacemaker systems but remains relatively contraindicated with non-MR-conditional pacemaker systems. ⋯ MRI scans can be performed safely without positioning restrictions in patients with Medtronic CapSureFix Novus 5076 leads connected to an MR-conditional pacemaker.
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Multicenter Study Clinical Trial
Performance of a novel left ventricular lead with short bipolar spacing for cardiac resynchronization therapy: primary results of the Attain Performa quadripolar left ventricular lead study.
The Medtronic Attain Performa quadripolar leads provide 16 pacing vectors with steroid on every electrode. This includes a short bipolar configuration between the middle 2 electrodes. ⋯ This large multicenter study demonstrated a high success rate for the implantation of Attain Performa quadripolar LV leads with a low complication rate. The PCT was low and stable over time. A low rate of postimplantation PNS was observed, and cases of PNS were readily resolved with reprogramming. Nonstandard vectors were often used for LV pacing.
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Multicenter Study Clinical Trial
Thoracic Spinal Cord Stimulation for Heart Failure as a Restorative Treatment (SCS HEART study): first-in-man experience.
Preclinical studies suggest that neuromodulation with thoracic spinal cord stimulation (SCS) improves left ventricular (LV) function and remodeling in systolic heart failure (HF). ⋯ The results of this first-in-human trial suggest that high thoracic SCS is safe and feasible and potentially can improve symptoms, functional status, and LV function and remodeling in patients with severe, symptomatic systolic HF.