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RIsk Stratification prior to lead Extraction and impact on major intraprocedural complications (RISE protocol)
Muhammad R Afzal1, Emile G Daoud1, Nancy Matre1
1Department of Internal Medicine, Division of Cardiovascular Medicine, Wexner Medical Center at the Ohio State University Medical Center, Columbus, Ohio.
Insights
The RISE protocol for lead extraction effectively reduced major adverse cardiac events (MACEs) by stratifying patients into high- and low-risk groups. This risk stratification optimized resource allocation and improved patient outcomes during lead extraction procedures.
Area of Science:
- Cardiology
- Electrophysiology
- Medical Device Technology
Background:
- Developing effective strategies to mitigate risks associated with lead extractions (LEs) is crucial for patient safety.
- Major adverse cardiac events (MACEs) are significant complications during cardiac device lead removal.
- A need exists for a systematic approach to stratify patients undergoing LEs based on their risk profile.
Purpose of the Study:
- To evaluate the impact of the RIsk Stratification prior to lead Extraction (RISE) protocol on MACEs during LEs.
- To determine if the RISE protocol can optimize resource utilization in a high-volume center.
- To assess the effectiveness of risk stratification in improving outcomes for patients undergoing LEs.
Main Methods:
- A retrospective analysis of a prospectively maintained LEs database identified MACE predictors.
- The RISE protocol categorized LEs into "High" and "Low" risk based on lead type, duration, and specific lead models.
- Prospective implementation compared outcomes between pre-RISE and post-RISE periods, with distinct resource allocation for each risk category.
Main Results:
- The incidence of MACEs decreased significantly from 3.34% in the pre-RISE group (449 patients) to 1.6% in the post-RISE group (751 patients) (P=.04).
- Protocol compliance was 100%, indicating successful implementation of the risk stratification strategy.
- The RISE protocol successfully differentiated LE procedures, guiding appropriate resource allocation.
Conclusions:
- The RISE protocol effectively stratifies patients for lead extraction, identifying low-risk cases requiring minimal resources.
- Implementation of the RISE protocol led to a significant reduction in MACEs during lead extractions.
- The RISE protocol facilitates targeted interventions for high-risk patients, thereby mitigating adverse cardiac events.
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.
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