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Initial clinical experience with distal protection using the FilterWire in patients undergoing coronary artery and
Jeffrey J Popma1, Nicholas Cox, K Eugene Hauptmann
1Department of Internal Medicine, Brigham and Women's Hospital, Boston, Massachusetts 02115, USA. jpopma@partners.org
Insights
The FilterWire device safely captures embolic debris during percutaneous coronary intervention (PCI) in saphenous vein grafts (SVG) and native arteries. This study shows the FilterWire is feasible for collecting debris, with low rates of adverse events.
Area of Science:
- Interventional Cardiology
- Cardiovascular Devices
- Biomedical Engineering
Background:
- Percutaneous coronary intervention (PCI) in saphenous vein grafts (SVG) and native coronary arteries carries a risk of embolic debris release.
- Embolization of particulate matter can lead to distal microcirculation complications.
- Distal protection devices aim to mitigate risks associated with PCI-induced embolization.
Purpose of the Study:
- To assess the feasibility and safety of the FilterWire device during PCI.
- To evaluate the size and content of particulate debris captured by the FilterWire.
- To analyze early clinical outcomes in patients undergoing PCI with FilterWire protection.
Main Methods:
- A prospective review of 35 patients (36 lesions) treated with the FilterWire during PCI.
- The FilterWire, a filter bag on a radiopaque loop, was deployed distal to the intervention site.
- Analysis included device delivery success, debris capture, flow dynamics, and clinical outcomes (angiographic, in-hospital, 30-day).
Main Results:
- Successful FilterWire deployment was achieved in 92% of lesions (95% native arteries, 82% SVGs).
- Embolic debris was entrapped in 82% of cases, with debris measuring up to 3,302 microm.
- Low rates of sustained no-reflow (2.8%) and distal embolization (11.1%) were observed; 6% major adverse cardiac events in eligible patients.
Conclusions:
- The FilterWire demonstrates feasibility and safety as a method for collecting embolic debris during PCI.
- The device effectively captures particulate matter released from both native coronary arteries and SVGs.
- Further studies are needed to compare the FilterWire's benefits against conventional therapies and other distal protection devices.
Abstract:
Percutaneous coronary intervention (PCI) of saphenous vein grafts (SVG) and native coronary arteries may be associated with embolization of particulate debris into the distal microcirculation. The FilterWire uses a polyurethane filter bag contained on a radiopaque loop to trap embolic debris during native vessel and SVG intervention. The objectives of this study were to assess the feasibility and safety of the FilterWire during PCI and to examine the size and content of the particulate debris captured during SVG and native vessel intervention. Early angiographic, in-hospital, and 30-day clinical outcomes were reviewed in 35 patients with 36 lesions treated with the FilterWire during PCI. Lesions were located in 22 (61%) native coronary arteries and in 14 (39%) SVGs. Multivessel coronary artery disease was present in 75% of patients. Lesions were complex (ACC/AHA complexity B2 or C) in 81% of cases. The FilterWire was successfully delivered and deployed distal to the site of coronary intervention in 92% of lesions, including 95% of native vessels and 82% of SVG lesions. Embolic debris was entrapped in 82% of these cases. The average particulate debris had a mean major axis of 490 microm (range, 45-3,302 microm) and minor axis of 226 microm (range, 33-1,677 microm). Although reduced flow was common (36.1%) when the FilterWire was in place, there were no sustained episodes of abrupt closure and only one (2.8%) patient developed sustained no-reflow after FilterWire removal. Distal branch vessel embolization was found in four (11.1%) cases. Major adverse cardiac events occurred in 5 (14%) of 35 patients treated with the device, although 2 of these patients were evolving an acute myocardial infarction at the time of the procedure; in patients meeting the prospectively defined inclusion criteria, the major adverse cardiac event was 6%. These results suggest that the FilterWire is a feasible and safe method of collecting particulate debris released during SVG and native vessel coronary intervention. Its benefit over conventional therapy and other distal protection devices is currently under study.
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