Christian Butter (Heart Center Brandenburg, Bernau bei Berlin, Germany) was awarded best abstract at the XVII International Symposium on Progress in Clinical Pacing (29 November‒2 December, Rome, Italy) for his presentation of the final outcomes of the SELECT-LV clinical trial of the WiSE (Wireless Stimulation of the Endocardium) CRT System (EBR Systems).
The final results of the European prospective, non-randomised, multicentre SELECT-LV trial, demonstrated the feasibility and promising efficacy of the WiSE CRT System for heart failure treatment.
SELECT-LV enrolled 39 failed cardiac resynchronisation therapy (CRT) patients who were classified as untreated, non-responders or upgrades.
Butter reported a 97.1% successful implant rate. He noted that from the 39 patients enrolled, three patients failed screening and one patient withdrew pre-implant. At one-month follow-up, biventricular pacing was demonstrated in 33 of 34 patients (97.1%) and in 31 of 33 patients (93.9%) at six months.
Also at six month-follow up, 66.7% of patients showed improvement in one or more than one New York Heart Association (NYHA) class; 52% of patients improved left ventricular (LV) end systolic volume in ≥15%; 62.5% of patients demonstrated ≥5% increase in ejection fraction and 84.8% of patients showed improvement in their clinical composite score.
There were three adverse events in three patients (8.6%) peri-operatively and nine adverse events in nine patients (25.7%) by one-month follow-up, Butter noted.
In conclusion, “this multicentre experience demonstrated the feasibility of wireless LV endocardial pacing; thereby providing new hope to patients with previous CRT failure,” Butter said.
The CE marked WiSE CRT System provides wireless LV stimulation. The system includes a sub-muscularly implanted transmitter and a wireless electrode implanted on the LV endocardial free wall. The transmitter emits an ultrasonic pulse synchronised with the right ventricular pacing pulse; the electrode converts the ultrasonic energy into electrical energy to achieve synchronous biventricular pacing.
Final results of the SELECT-LV clinical trial were also presented in 2016 at the Heart Rhythm Society Scientific Sessions (HRS; 4‒7 May, San Francisco, USA) and CARDIOSTIM-EHRA EUROPACE (8‒11 June, Nice, France).