Key result
WiSE-CRT wireless LV pacing achieves biventricular capture in ~97% of patients at 1 month.
Why the study?
Approximately 30% to 40% of heart failure patients eligible for CRT do not respond to conventional CRT or remain untreated due to failed coronary sinus lead implantation. The safety and performance of the wireless LV endocardial pacing WiSE-CRT system in this population needed evaluation.
Is wireless left ventricular endocardial pacing with the WiSE-CRT system safe and effective for achieving biventricular pacing in heart failure patients who have failed conventional CRT?
Is wireless left ventricular endocardial pacing with the WiSE-CRT system safe and effective for achieving biventricular pacing in heart failure patients who have failed conventional CRT?
Wireless LV endocardial pacing with the WiSE-CRT system is technically feasible and provides clinical and echocardiographic improvements in a high proportion of heart failure patients who failed conventional CRT, though procedural and vascular complications warrant attention.
Answers are grounded in this paper and cite their sources.
May offer rescue pacing for CRT failures; leaves open randomized confirmation of long-term safety and benefit.
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).
No takes yet. Share an insight, caveat, or question.
Reddy et al. (2017) studied Congestive heart failure indicated for CRT who failed conventional CRT (n=35). WiSE-CRT system (wireless left ventricular endocardial pacing electrode and subcutaneous ultrasound pulse generator) was evaluated on Biventricular pacing on the 12-lead electrocardiogram at 1 month. The WiSE-CRT wireless LV endocardial pacing system achieved the primary endpoint of biventricular pacing at 1 month in 97.1% (33/34) of patients and improved clinical composite scores in 84.8% at 6 months.
Synapse has enriched 10 related papers. Consider them for comparative context: