Cardiac Resynchronization Therapy With Wireless Left Ventricular Endocardial Pacing: The SELECT-LV Study
Language English Country United States Media print
Document type Clinical Trial, Journal Article, Multicenter Study
PubMed
28449772
DOI
10.1016/j.jacc.2017.02.059
PII: S0735-1097(17)36110-7
Knihovny.cz E-resources
- Keywords
- cardiac resynchronization therapy, leadless pacemaker,
- MeSH
- Middle Aged MeSH
- Humans MeSH
- Treatment Failure MeSH
- Prospective Studies MeSH
- Cardiac Resynchronization Therapy Devices adverse effects statistics & numerical data MeSH
- Aged MeSH
- Cardiac Resynchronization Therapy adverse effects statistics & numerical data MeSH
- Heart Failure therapy MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial MeSH
- Multicenter Study MeSH
BACKGROUND: A total of 30% to 40% of patients with congestive heart failure eligible for cardiac resynchronization therapy (CRT) either do not respond to conventional CRT or remain untreated due to an inability or impediment to coronary sinus (CS) lead implantation. The WiSE-CRT system (EBR Systems, Sunnyvale, California) was developed to address this at-risk patient population by performing biventricular pacing via a wireless left ventricular (LV) endocardial pacing electrode. OBJECTIVES: The SELECT-LV (Safety and Performance of Electrodes implanted in the Left Ventricle) study is a prospective multicenter non-randomized trial assessing the safety and performance of the WiSE-CRT system. METHODS: A total of 35 patients indicated for CRT who had "failed" conventional CRT underwent implantation of an LV endocardial pacing electrode and a subcutaneous pulse generator. System performance, clinical efficacy, and safety events were assessed out to 6 months post-implant. RESULTS: The procedure was successful in 97.1% (n = 34) of attempted implants. The most common indications for endocardial LV pacing were difficult CS anatomy (n =12), failure to respond to conventional CRT (n = 10), and a high CS pacing threshold or phrenic nerve capture (n = 5). The primary performance endpoint, biventricular pacing on the 12-lead electrocardiogram at 1 month, was achieved in 33 of 34 patients. A total of 28 patients (84.8%) had improvement in the clinical composite score at 6 months, and 21 (66%) demonstrated a positive echocardiographic CRT response (≥5% absolute increase in LV ejection fraction). There were no pericardial effusions, but serious procedure/device-related events occurred in 3 patients (8.6%) within 24 h, and 8 patients (22.9%) between 24 h and 1 month. CONCLUSIONS: The SELECT-LV study demonstrates the clinical feasibility for the WiSE-CRT system, and provided clinical benefits to a majority of patients within an otherwise "failed" CRT population. (Safety and Performance of Electrodes Implanted in the Left Ventricle [SELECT-LV]; NCT01905670).
Cardiac Arrhythmia Service Icahn School of Medicine at Mount Sinai New York New York
Division of Cardiology Aalborg University Hospital Aalborg Denmark
Division of Cardiology Herzzentrum Brandenburg in Bernau Bernau bei Berlin Germany
Division of Cardiology Homolka Hospital Prague Czech Republic
Division of Cardiology Isala Hospital Zwolle the Netherlands
Division of Cardiology Leiden University Medical Center Leiden the Netherlands
Division of Cardiology St Antonius Ziekenhuis Nieuwegein the Netherlands
References provided by Crossref.org
European experience with a first totally leadless cardiac resynchronization therapy pacemaker system
Successful implementation of a totally leadless biventricular pacing approach
ClinicalTrials.gov
NCT01905670
