A Prospective Multicenter Study Using a Virtual 3 Fr Percutaneous Coronary Intervention System: The V3 Registry.
OBJECTIVE
To evaluate the safety and feasibility of virtual 3 Fr (V3), sheathless 5 Fr percutaneous coronary intervention (PCI).


BACKGROUND
A small-diameter guiding catheter (GC) makes less-invasive PCI possible. The V3 is an extremely slender PCI system; however, the outcome of using this system has not yet been determined.


METHODS
The V3 registry is a prospective, multicenter, non-randomized study that enrolled patients who underwent elective V3-PCI. The primary endpoint was clinical success rate, and the secondary endpoints were PCI success rate in all cases, major adverse cardiac and cerebrovascular event (MACCE) at 30 days, and access-site complications.


RESULTS
A total of 260 patients with 321 lesions were enrolled. Of this group, 70% were male and the mean age was 70.8 ± 10.0 years. Type B2/C lesions comprised 50.7% of the total. The clinical success rate was 95.8%, and the PCI success rate was 99.2%. PCI failure was reported in 2 chronic total occlusion cases. No MACCE was reported. Although there was no major bleeding, hematoma occurred at the puncture site in 12.7% of cases. There was a single radial artery occlusion (0.4%) without symptoms.


CONCLUSIONS
PCI with the V3 was safe and feasible. Radial artery occlusion and major bleeding complications were extremely low. However, access-site hematoma frequently complicated catheter exchange.
Department of Cardiology, Tokai University School of Medicine, 143 Shimo Kasuya, Isehara, Kanagawa 259-1193, Japan. yoshimachi-circ@umin.ne.jp.
Fuminobu
F
Yoshimachi
Yoshitoki
Y
Takagawa
Hidenobu
H
Terai
Akihiko
A
Takahashi
Yoshihisa
Y
Shimada
Takaaki
T
Katsuki
Satoru
S
Tohara
Hiroshi
H
Ueno
Masanori
M
Takada
Nobuo
N
Shiode
Kunihiro
K
Yamada
Noriyuki
N
Kinoshita
Tsuyoshi
T
Honda
Hiroshi
H
Asano
Satoshi
S
Takeshita
Hiroaki
H
Koiwa
Tomoyasu
T
Shin
Motomaru
M
Masutani
Takashi
T
Matsukage
Shigeru
S
Saito
Yuji
Y
Ikari
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D062906:Cardiac Catheters; D023921:Coronary Stenosis / Q000175:diagnosis / Q000601:surgery*; D004867:Equipment Design; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D062645:Percutaneous Coronary Intervention / Q000295:instrumentation*; D011446:Prospective Studies; D012042:Registries; D016896:Treatment Outcome; D014584:User-Computer Interface