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

Abstract

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.

LECOM (Lead Extraction COMplexity): A New Scoring System for Predicting a Difficult Procedure

“…Pre-procedural assessment of the risk level associated with transvenous lead extraction procedures has been the subject of numerous reports [4][5][6][7][8][9][10][11][12][13]. First, the most important risk factors [3][4][5][6][7][8][9][10][11][12][13][14] were established, in order to identify the patients at highest risk of major complications related to TLE. Later, attempts were made to develop advanced scoring systems for more precise determinations of increased procedural complexity [10,13,14].…”

“…First, the most important risk factors [3][4][5][6][7][8][9][10][11][12][13][14] were established, in order to identify the patients at highest risk of major complications related to TLE. Later, attempts were made to develop advanced scoring systems for more precise determinations of increased procedural complexity [10,13,14]. Finally, the ELECTRa Registry Outcome Score (EROS) was developed [13] and used for comparison, although the SAFeTY-TLE score for predicting the risk of major complications during TLE [14] seems to be most useful at present.…”

Lead extraction risk scores and practical use: literature review

“…RISE протокол RISE-протокол (RIsk Stratification prior to lead Extraction) предложен группой авторов из США в 2019 году. Авторы разделили экстракции на две группы: высокого риска (High-risk) и низкого риска (Low-risk) [12]. К группе высокого риска они отнесли двуспиральные ДЭ длительностью имплантации ≥ 3 лет, СЭ или ДЭ односпиральные электроды со сроком 5 лет и более, а также все левожелудочковые электроды модели StarFix (Medtronic, USA) (рис.…”

“…Исследование включило pre-RISE группу (449 пациентов, которым было удалено 632 электрода) и post-RISE группу (751 пациентов, 1055 электродов). В результате введения протокола авторам удалось более чем в два раза снизить риск развития больших осложнений -с 3,34% до 1,6% (P=0,04), а летальности с 0,89% до 0,13% (P=0,04) [12].…”