Introduction

Percutaneous coronary intervention (PCI) is a cornerstone therapy for patients with ischemic heart disease. However, one of the most feared complications during PCI is coronary artery perforation. If untreated, perforation can result in cardiac tamponade and life-threatening hemodynamic compromise.

To address such emergencies, Abbott developed the GRAFTMASTER™ RX Coronary Stent Graft System. This article explains its purpose, indications in Japan, technical specifications, benefits, risks, and practical considerations for interventional cardiologists.

What is the GRAFTMASTER RX?

The GRAFTMASTER RX is a specialized coronary stent graft designed specifically to seal vessel perforations. Unlike drug-eluting or bare-metal stents, its purpose is not routine revascularization but emergency use in PCI complications.

Key Features

• Dual stent structure — Two stainless-steel stents sandwiching an ePTFE membrane to seal the perforation.
• Rapid Exchange (RX) system — Enables fast deployment in critical situations.
• Emergency focus — Serves as a life-saving tool for perforation management, not as a standard stent option.

Indications in Japan

In Japan, the GRAFTMASTER RX is approved for:

Emergency treatment of patients with coronary artery or saphenous vein graft perforations that result in uncontrollable bleeding into the pericardial space.

This strict indication means it is not intended for elective use but solely for life-threatening perforations during PCI.

Technical Specifications

Clinical Benefits

• Immediate hemostasis — Rapid sealing of perforations to prevent tamponade.
• Quick deployment — RX system minimizes delay in emergencies.
• Adaptability — Multiple diameters and lengths for varied anatomies.

Risks and Limitations

• Limited long-term data — Emergency use limits evidence on restenosis or thrombosis.
• Allergic contraindications — Not suitable for patients allergic to stainless steel (nickel, chromium) or PTFE.
• Potential complications — Thrombosis, restenosis, or side-branch occlusion.
• Technical cautions
  • Avoid balloon over-inflation beyond rated pressure.
  • When multiple grafts are needed, deploy the distal graft first to reduce crossing risks.

Practical Considerations

• Device selection — Ensure the chosen size fully covers the perforation with proper margins.
• Imaging support — IVUS or OCT can confirm correct placement.
• Cath lab readiness — Because perforations are unpredictable, GRAFTMASTER should always be available in the cath lab inventory.

Conclusion

Abbott’s GRAFTMASTER RX Coronary Stent Graft System is a critical life-saving device for managing coronary perforations during PCI.

In Japan, its use is strictly limited to emergency cases, but its rapid sealing capability makes it indispensable in the catheterization lab. For interventional cardiologists, understanding the device’s indications, specifications, and technical precautions is essential for ensuring patient safety in high-risk PCI procedures.

What is Intravascular Ultrasound (IVUS)?

Intravascular Ultrasound (IVUS) is a medical imaging technique used during catheter-based procedures to visualize the inside of blood vessels from within. A miniature ultrasound probe is mounted on the tip of a catheter and inserted into the vessel, usually during percutaneous coronary interventions (PCI).

IVUS provides real-time, cross-sectional images of the vessel walls, allowing physicians to assess plaque burden, vessel size, and lesion morphology. It is especially valuable for planning stent placement and optimizing stent deployment by giving a more accurate picture than traditional angiography alone.

Scoring balloons come in different designs — some with metal blades on the balloon surface, others with nylon scoring elements or Nitinol wires that wrap around the balloon for controlled lesion modification.

One of the key benefits is the lower risk of major vessel dissection, making it more likely that the procedure can be completed with a DCB (drug-coated balloon) rather than stent implantation.

In the past, crossing performance was a major concern, and these devices were used only in carefully selected cases.
However, today’s devices have significantly improved in deliverability, and they are now being used in a wider range of clinical situations.

Unlike standard balloons, scoring balloons have blades or scoring elements attached, so careful attention is needed when selecting the balloon diameter.