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A Prospective Multicenter Study Using a Virtual 3 Fr Percutaneous Coronary Intervention System: The V3 Registry.

Fuminobu Yoshimachi1, Yoshitoki Takagawa, Hidenobu Terai

  • 1Department of Cardiology, Tokai University School of Medicine, 143 Shimo Kasuya, Isehara, Kanagawa 259-1193, Japan. yoshimachi-circ@umin.ne.jp.

The Journal of Invasive Cardiology
|June 18, 2016
PubMed
Summary

The virtual 3 Fr (V3) sheathless percutaneous coronary intervention (PCI) system is safe and feasible for patients. While major complications were rare, access-site hematoma was common during catheter exchange.

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Area of Science:

  • Cardiology
  • Interventional Cardiology
  • Medical Devices

Background:

  • Small-diameter guiding catheters (GCs) enable less-invasive percutaneous coronary intervention (PCI).
  • The virtual 3 Fr (V3) system represents an extremely slender PCI option.
  • Outcomes associated with the V3 system required further investigation.

Purpose of the Study:

  • To assess the safety and feasibility of the virtual 3 Fr (V3) sheathless percutaneous coronary intervention (PCI) system.
  • To determine the clinical and procedural success rates of V3 PCI.
  • To evaluate adverse events, including major adverse cardiac and cerebrovascular events (MACCE) and access-site complications.

Main Methods:

  • Prospective, multicenter, non-randomized V3 registry study.
  • Enrolled patients undergoing elective V3 PCI.
  • Primary endpoint: clinical success rate; Secondary endpoints: PCI success rate, MACCE at 30 days, access-site complications.

Main Results:

  • 260 patients (321 lesions) enrolled; 70% male, mean age 70.8 years.
  • Clinical success rate: 95.8%; PCI success rate: 99.2%.
  • No MACCE reported; 12.7% experienced access-site hematoma; 0.4% radial artery occlusion.

Conclusions:

  • Percutaneous coronary intervention (PCI) using the V3 system is safe and feasible.
  • Extremely low rates of radial artery occlusion and major bleeding were observed.
  • Access-site hematoma was a frequent complication, particularly during catheter exchange.