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Safety and efficacy of a new filter-based protection system for aorto-coronary bypass graft interventions: the ev3
Hubertus von Korn1, Jiangtao Yu, Burckhard Huegl
1Klinik fur Kardiologie, Robert-Koch-Allee 9, Bad Berka, Germany, 99437. h.korn.kar@zentralklinik-bad-berka.de
Insights
The Spider system offers a high success rate for treating bypass graft stenosis, achieving excellent blood flow with no macroembolism. However, risks of microembolism and periprocedural myocardial infarction persist.
Area of Science:
- Cardiovascular Interventions
- Medical Device Technology
Background:
- Aorto-coronary bypass graft treatment without protection devices leads to significant ischemic events.
- The Spider system represents a novel embolic protection device for these procedures.
Purpose of the Study:
- To evaluate the feasibility and efficacy of the Spider system in treating aorto-coronary bypass graft stenosis.
- To assess the incidence of ischemic events and technical success rates using this new protection device.
Main Methods:
- A prospective study involving 40 patients with 50 bypass graft lesions (>50% stenosis).
- Utilized the Spider system for embolic protection during intervention.
- Follow-up included clinical records and 30-day phone calls.
Main Results:
- High technical success rate (92.5%) and excellent final TIMI flow (97.5%).
- Low incidence of no-reflow (10%) and major adverse cardiac events (10%).
- Debris retrieval occurred in 52.5%; microembolism and periprocedural myocardial infarction were observed in a subset of patients.
Conclusions:
- The Spider system is a feasible embolic protection device for bypass graft interventions.
- It demonstrates a high technical success rate and excellent final flow.
- While effective in preventing macroembolism, the risk of microembolism and periprocedural myocardial infarction requires further consideration.
Purpose:
Treatment of aorto-coronary bypass grafts without a protection devices is associated with a high incidence of ischemic events. The Spider(R) system is a new protection device.
Methods And Results:
We included 40 consecutive patients with 50 lesions and stenosis > 50% in bypass grafts. Follow-up was performed according to clinical records and by phone call after 30 days. Final TIMI flow 2 or 3 was observed in 97.5% of the patients, and no-reflow occurred in 10% without incidence of macroembolism. The technical success rate was 92.5%. A new rise of creatine kinase or troponin was observed in 27.5% after treatment, but 8 of 11 patients (72.7%) had only a periprocedural rise of troponin without elevation of creatine kinase. Debris was found in 52.5%, MACE rate was low (10%). Both types of stenoses (types A and B) were embolic, we found a trend for more frequent entrapped debris and periprocedural elevation of ischemic markers in type B stenoses, but these did not reach a significant level.
Conclusion:
Using the Spider system is feasible, and offers a high technical success rate, no macroembolism, and excellent final TIMI flow, but the risk of microembolism and periprocedural myocardial infarction is not entirely eliminated.
