Clinical outcome of implantable cardioverter defibrillators with recalled and non-recalled leads in Japanese patients. Increased failure rate of the Sprint Fidelis lead.

BACKGROUND: In recent years, there has been a series of recalls of popular implantable cardioverter defibrillators leads, and several reports have demonstrated an increasing rate of failure of such leads over time in Caucasian patients. However, little is known about the performance of these leads in Asian patients. The aim of this study was to investigate the rate of failure of the recalled leads and the characteristics as compared with non-recalled leads in Japanese patients. METHODS AND RESULTS: A retrospective chart review was conducted in 214 patients (75 Sprint Fidelis, 8 Riata, and 131 Sprint Quattro leads) who underwent implantation and follow-up at Nagoya University Hospital. During the follow-up period, 14 Sprint Fidelis leads (19%) and 1 Riata lead (13%) failed, but no abnormality was found in the Sprint Quattro, non-recalled leads. Five patients (4 Sprint Fidelis and 1 Riata, 33% of lead failure patients) received inappropriate shocks. The 3-, 4-, and 5-year lead survival rates in Sprint Fidelis leads were 95.1% (95% confidence interval [CI]: 89.6%-100%), 89.8% (95% CI: 82.1%-97.6%), and 88.0% (95% CI: 79.6%-96.4%), respectively. A previous device implantation before Sprint Fidelis lead was the only significant predictor for lead fracture (hazard ratio, 5.33; 95% CI: 1.55-18.4; P=0.008). CONCLUSIONS: The rate of Sprint Fidelis lead failure continues to increase over time in Japanese patients.

C-arm-guided reduction of zygomatic fractures revisited.

BACKGROUND: Anatomic reduction of the zygomatic arch, a key surgical landmark for midfacial width and projection, is essential for the treatment of combined fractures of the zygomaticomaxillary complex and zygomatic arch. Reduction control in surgery for this common facial fracture would be facilitated by intraoperative real-time assessment using widely available and reliable equipment. Although C-arm fluoroscopy is routinely used in the repair of orthopedic fractures, its use in the maxillofacial region, particularly for combined zygomatic fractures, has been scarcely reported. METHODS: We prospectively evaluated C-arm-guided reduction in 38 patients of combined zygomatic fracture without concurrent craniofacial fractures. Patients were classified according to the presence or absence of bone contact in the displaced zygomatic arch, namely as conserved (C) and loss (L) types, respectively. Reduction status was determined by the degree of recovery of the malar prominence and arch shape. RESULTS: In all cases, C-arm imaging clearly displayed the displaced zygomatic arch and body in a single image. Cumulative fluoroscopic time was a few minutes in all cases. Total reduction status was excellent in 21 patients and good in 17. No case was classified as fair or poor. Repair was significantly more favorable in type C than in type L cases (p = 0.0016). CONCLUSIONS: In combined zygomatic fractures, the C-arm technique provides easy, flexible, and time-efficient adjustment. Its comprehensive imaging for zygomatic arch shape and body contour markedly facilitates the control of fracture reduction and protects against unexpected, unsatisfactory outcomes.