Spinal cord stimulation is safe and feasible in patients with advanced heart failure: early clinical experience

Abstract

Aims Pre‐clinical work suggests that upper thoracic spinal cord stimulation (SCS) may have therapeutic effects in the treatment of heart failure (HF). We therefore aim to assess the safety and feasibility of SCS in HF patients. Methods and results A prospective, randomized, double‐blind, crossover pilot study was conducted in symptomatic HF patients receiving optimal medical therapy. Patients were implanted with an SCS system and randomized to an SCS‐ACTIVE, delivered at 90% paraesthesia threshold, or an SCS‐INACTIVE phase for 3 months, followed by a 1‐month washout period and crossover to the alternative phase. The safety of SCS therapy was assessed by death and cardiac events. Implantable cardioverter defibrillator (ICD) function in the presence of SCS was tested by defibrillation testing during SCS system implant and review of real‐time and stored electrograms during follow‐up. The efficacy of SCS therapy was assessed by changes in patient symptoms, LV function, and BNP level. Nine patients were investigated. In all cases, ICD sensing, detection, and therapy delivery were unaffected by SCS. During follow‐up, one patient died and one was hospitalized for HF while in the SCS‐INACTIVE phase, and two patients had HF hospitalizations during the SCS‐ACTIVE phase. Symptoms were improved in the majority of patients with SCS, while markers of cardiac structure and function were, in aggregate, unchanged. Conclusion This study shows that an SCS system can be safely implanted in patients with advanced HF and that the SCS system does not interfere with ICD function.

Drivers and Risk Factors of Unplanned 30-Day Readmission Following Spinal Cord Stimulator Implantation

“…12 In a prospective, randomized study of 10 patients with heart failure undergoing SCS implantation conducted by Torre-Amione et al, one patient was readmitted due to infection around the implantable pulse generator site. 21 This finding is consistent with the predominance of infectious etiologies for unplanned 30-day readmissions in our cohort. However, we also reported non-infectious causes of readmission including mechanical complications and medical problems including cardiac complications and post-operative pain.…”

Interventional and Device-Based Autonomic Modulation in Heart Failure

“…The results of a smaller prospective trial that enrolled nine patients with LVEF ≤ 30% and NYHA class III HF symptoms while on optimal medical therapy have been published. 16 During the 7-month period of follow up, five patients had improved symptoms by at least one NYHA class and three were unchanged, while no one worsened. Despite the small sample size, this study demonstrated the safety and feasibility of SCS in patients with advanced HF.…”

“…[16][17][18][19] Of those trials the largest is DEFEAT-HF with implanted PrimeAdvanced neurostimulator (Medtronic Inc, Minneapolis, MN, USA). It is a multicenter, prospective, randomized (3:2 fashion) control trial enrolling 66 patients with LVEF ≤ 35%, NYHA class III HF symptoms while on optimal medical therapy, narrow QRS duration and a dilated LV.…”

High‐Frequency Spinal Cord Stimulation in a Patient with an Implanted Cardiac Device

“…It remains untested whether placement at higher levels might interfere with PPM/AICD function, and as a result, safety has not been established above the T9 to T10 junction with high‐frequency stimulation. There have been reports of improved symptomatic control in congestive heart failure with traditional SCS, but the effect on markers of cardiac structure and function has been inconsistent . If high‐frequency stimulation can be shown to be safe at higher vertebral levels, then this may be a potential therapeutic option for congestive heart failure and worth further study.…”