By Ahmed El-Medany
The SOLVE-CRT trial, presented by Dr Jagmeet P. Singh at Heart Rhythm 2021, examined implant complications and improvement in left ventricular ejection fraction (LVEF), and systolic and diastolic volumes following implantation of the novel Wise-CRT system – a wireless cardiac resynchronisation therapy (CRT) pacing strategy that involves implanting an LV electrode into the LV endocardium via a transfemoral or transeptal approach. Alongside this, there is an implanted subcutaneous ultrasound transmitter that sends ultrasonic waves to the LV electrode, allowing it to pace.
As part of phase I of the SOLVE-CRT trial, which is estimated to be completed in December 2025, the researchers enrolled 31 patients across 19 centres (mean age, 66 years; 42% women) with heart failure (HF) indicated for CRT who were previous non-responders to CRT, considered previously untreatable, or deemed too high-risk for conventional transvenous CRT upgrade of an implantable cardioverter defibrillator.30 patients completed 6 months of follow-up and demonstrated mean improvement in LVEF by 5.2% (p<.001). LV end-systolic volume declined by a mean of 20.5 mL (p=.0017) and LV end-diastolic volume reduced by a mean of 23.7 mL (p=.0004). There were 3 (9.7%) device-related complications: 1 insufficient LV pacing, 1 embolization of an unanchored LV electrode, and 1 skin infection.
Singh stated, ‘…overall, the results looked great. Hopefully, over the course of the next 12 months, we will finish recruitment for the final phase of the study to further confirm the primary safety and efficacy endpoints that we saw with the roll-in patients. And we may have the final results for the next HRS conference.’
More here: https://www.heartrhythmjournal.com/article/S1547-5271(21)01808-7/fulltext
Okabe T, Hummel JD, Bank AJ, Niazi IK, McGrew FA, Kindsvater S, Oza SR, Scherschel JA, Walsh MN, Singh JP. Leadless left ventricular stimulation with WiSE-CRT System–Initial experience and results from phase I of SOLVE-CRT Study (nonrandomized, roll-in phase). Heart Rhythm. 2021 Jul 29