RIsk Stratification prior to lead Extraction and impact on major intraprocedural complications (RISE protocol)

BACKGROUND An internal risk stratification algorithm was developed to decrease the risk of major adverse cardiac events (MACEs) during lead extractions (LEs). OBJECTIVE To report upon the impact of a risk stratification algorithm (RISE [RIsk Stratification prior to lead Extraction] protocol) on outcomes of LEs in a high-volume center. METHODS A retrospective review of a prospectively maintained LEs database was performed to identify features associated with MACEs. On the basis of the retrospective data, the RISE protocol differentiated LEs procedures into "High" and "Low" risk for occurrence of MACEs. High-risk LEs included dual-coil defibrillator lead (≥3 years), pacemaker and single-coil lead (≥5 years), and any StarFix coronary sinus lead. During the prospective evaluation of the RISE protocol, "High-risk" LEs were performed in an operating room (OR) or hybrid laboratory with the cardiac anesthesiologist, OR nursing team, perfusionist in the room, and a cardiac surgeon on the premises. "Low-risk" LEs were performed in the electrophysiology (EP) laboratory with anesthesia provided by EP nursing team. The preintervention (pre-RISE) and postintervention (post-RISE) group spanned 19 and 40 months and consisted of 449 (632 leads) and 751 patients (1055 leads), respectively. The primary outcome of MACEs in the two groups was compared. RESULTS Protocol compliance was 100%. The primary outcome of MACEs occurred in 15 patients (3.34%) before and 12 (1.6%) after implementation of the RISE protocol (P = .04). CONCLUSION RISE identified a low-risk group where minimal resources are needed and allowed for rapid intervention in the high-risk group that reduced the consequences of MACEs.