B-LBCT01-02 - A Randomized Pilot Study Of Perioperative Spinal Cord Stimulation To Prevent Post-cabg Atrial Fibrillation: 30-day Safety And Efficacy Outcomes
Author Block: Alexander B. Romanov, MD, PhD, FHRS; Vladimir Lomivorotov, MD, PhD; Alexander Chernyavskiy, MD, PhD; Vladimir Murtazin, MD; Elena Kliver, MD; Dmitry Ponomarev, MD, PhD; Igor Mikheenko, MD; Alexander Yakovlev, MD; Marina Yakovleva, MD; Jonathan S. Steinberg, MD, FHRS
Disclosure Block: A.B. Romanov: Research (Contracted Grants for PIs and Named Investigators only) - Boston Scientific; Biosense Webster, Inc..
Introduction: Spinal cord stimulation (SCS) has been shown to be effective in the treatment of chronic pain and intractable angina pectoris. Recently, animal studies have demonstrated that SCS can also suppress atrial fibrillation (AF).
Methods: Fifty two patients with indications for coronary artery bypass grafting (CABG) and history of paroxysmal AF were randomized to 2 groups: CABG plus standard medical therapy (MED) with beta-blockers (n=26, Control group) and CABG plus MED plus percutaneous lead placement for temporary SCS (n=26, SCS group). In the SCS group under local anesthesia and with fluoroscopic guidance, temporary leads were placed at C7-T4 level according to patient’s sense of paresthesia and connected to a SC stimulator externally fixed on patient’s chest. Temporary SCS was begun 3 days before elective CABG, deactivated during surgery, reactivated in the intensive care unit after CABG, and continued for 7 days at which time the leads were removed Continuous external ECG monitoring was performed for 30 days after CABG in all patients. These primary objectives were tested over the 30-day postoperative period: 1) occurrence of adverse events, including death, stroke or TIA, myocardial infarction and kidney injury; and 2) occurrence of AF or any atrial tachyarrhythmia lasting ≥ 30 seconds.
Applications: Percutaneous lead placement for temporary SCS was successfully performed in all 26 patients before CABG without any complications. There were no any adverse events related to temporary SCS in any patient throughout follow-up. There were no significant differences in CK-MB and creatinine levels between groups (p=0.1 and 0.2, respectively) as well as other typical CABG-related complications (p>0.05). Postoperative AF occurred in 8 (30.7%) of 26 patients in the Control group versus only 1 (3.8%) of 26 patients in the SCS group (p=0.012, log-rank test, Figure).
Next Steps/Future: Temporary SCS was effective in suppressing postoperative AF after CABG without any adverse events in this randomized pilot study (NCT 03539354). Further studies of SCS with larger samples are indicated to test its clinical value as a perioperative intervention.