Usefulness of delivery catheter on accurate right ventricular septal pacing: Mt FUJI trial
Yoshihisa Naruse, Makoto Sano, Nobutake Kurebayashi, Shuji Morikawa, Naoki Tsurumi, Tomoyuki Shiozawa, Shintaro Takano, Michio Ogano, Kei Kimura, Keisuke Miyajima, Ryo Sugiura, Ryuta Henmi, Masahiro Muto, Natsuko Hosoya, Hideyuki Hasebe, Akira Mizukami, Keisuke Iguchi, Akiko Atsumi, Keiichi Odagiri, Yumi Kiyama, Yuichiro Maekawa, the Mt FUJI trial investigators, Yoshinobu Kato, Saito Hideki, Isomura Daichi, Kazuki Ito, Ayako Okazaki, Takashima Yasuyo, Watanabe Tomoyuki, Yoshitaka Kawaguchi, Yasushi Wakabayashi, Yohei Takayama, Sawasaki Kohei, Jun Tanabe, Moriya Soushi, Ishikawa Go, Takahashi Daigo, Ryota Nishio, Kentaro Yasuda, Sonoda Taketo, Shoichiro Yatsu, Jun Shitara, Hideki Wada, Manabu Ogita, Suwa Satoru, Joko Yumiko, Ogane Takashi, Tomotaka Suzuki, Iwawaki Tomoya, Naoya Inoue, Urushida Tuyoshi, Masao Saotome, Hayato Ohtani, Kenichiro Suwa, Satoshi Mogi, Narumi Taro, Tomoaki Sakakibara, Yutaro Kaneko
Abstract
AIMS: Although the delivery catheter system for pacemaker-lead implantation is a new alternative to the stylet system, no randomized controlled trial has addressed the difference in right ventricular (RV) lead placement accuracy to the septum between the stylet and the delivery catheter systems. This multicentre prospective randomized controlled trial aimed to prove the efficacy of the delivery catheter system for accurate delivery of RV lead to the septum. METHODS AND RESULTS: In this trial, 70 patients (mean age 78 ± 11 years; 30 men) with pacemaker indications of atrioventricular block were randomized to the delivery catheter or the stylet groups. Right ventricular lead tip positions were assessed using cardiac computed tomography within 4 weeks of pacemaker implantation. Lead tip positions were classified into RV septum, anterior/posterior edge of the RV septal wall, and RV free wall. The primary endpoint was the success rate of RV lead tip placement to the RV septum. RESULTS: Right ventricular leads were implanted as per allocation in all patients. The delivery catheter group had higher success rate of RV lead deployment to the septum (78 vs. 50%; P = 0.024) and narrower paced QRS width (130 ± 19 vs. 142 ± 15 ms P = 0.004) than those in the stylet group. However, there was no significant difference in procedure time [91 (IQR 68-119) vs. 85 (59-118) min; P = 0.488] or the incidence of RV lead dislodgment (0 vs. 3%; P = 0.486). CONCLUSION: The delivery catheter system can achieve a higher success rate of RV lead placement to the RV septum and narrower paced QRS width than the stylet system. TRIAL REGISTRATION NUMBER: jRCTs042200014 (https://jrct.niph.go.jp/en-latest-detail/jRCTs042200014).