Safety, Performance, and Efficacy of Cardiac Contractility Modulation Delivered by the 2-Lead Optimizer Smart System
| Autor: | R. C. Chan, Benjamin R. Saville, David Prutchi, Rochelle L. Goldsmith, Daniel Burkhoff, Helen Parise, Angela Stagg, Charles Jost, Phi Wiegn, Peter E. Carson |
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| Rok vydání: | 2020 |
| Předmět: |
Male
Pacemaker Artificial medicine.medical_specialty Time Factors Ventricular Function Left Cardiac contractility modulation Risk Factors Internal medicine medicine Humans Prospective Studies Lead (electronics) Aged Heart Failure Smart system business.industry Cardiac Pacing Artificial Stroke Volume Atrial fibrillation Equipment Design Recovery of Function Middle Aged medicine.disease Myocardial Contraction Atrial Lead Treatment Outcome Heart failure Cardiology Female Cardiology and Cardiovascular Medicine business |
| Zdroj: | Circulation: Heart Failure. 13 |
| ISSN: | 1941-3297 1941-3289 |
| DOI: | 10.1161/circheartfailure.119.006512 |
| Popis: | Background: Prior studies of cardiac contractility modulation (CCM) employed a 3-lead Optimizer system. A new 2-lead system eliminated the need for an atrial lead. This study tested the safety and effectiveness of this 2-lead system compared with the 3-lead system. Methods: Patients with New York Heart Association III/IVa symptoms despite medical therapy, left ventricular ejection fraction 25% to 45%, and not eligible for cardiac resynchronization therapy could participate. All subjects received an Optimizer 2-lead implant. The primary end point was the estimated difference in the change of peak VO 2 from baseline to 24 weeks between FIX-HF-5C2 (2-lead system) subjects relative to control subjects from the prior FIX-HF-5C (3-lead system) study. Changes in New York Heart Association were a secondary end point. The primary safety end point was a comparison of device-related adverse events between FIX-HF-5C2 and FIX-HF-5C subjects. Results: Sixty subjects, 88% male, 66±9 years old with left ventricular ejection fraction 34±6% were included. Baseline characteristics were similar between FIX-HF-5C and FIX-HF-5C2 subjects except that 15% of FIX-HF-5C2 subjects had permanent atrial fibrillation versus 0% in FIX-HF-5C. CCM delivery did not differ significantly between 2- and 3-lead systems (19 892±3472 versus 19 583±4998 CCM signals/day, CI of difference [−1228 to 1847]). The change of peak VO 2 from baseline to 24 weeks was 1.72 (95% Bayesian credible interval, 1.02–2.42) mL/kg per minute greater in the 2-lead device group versus controls. 83.1% of 2-lead subjects compared with 42.7% of controls experienced ≥1 class New York Heart Association improvement ( P P =0.03). Conclusions: The 2-lead system effectively delivers comparable amount of CCM signals (including in subjects with atrial fibrillation) as the 3-lead system, is equally safe and improves peak VO 2 and New York Heart Association. Device-related adverse effects are less with the 2-lead system. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03339310 |
| Databáze: | OpenAIRE |
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