ABSTRACT
AIMS: Riata® implantable cardioverter-defibrillator (ICD) leads from St. Jude Medical are prone to malfunction. This study aimed to describe the rate of this lead's malfunction in a very long-term follow-up. METHODS: This single-centre observational study included 50 patients who received a Riata 7Fr dual-coil lead between 2003 and 2008. Follow-up was conducted both in person and remotely, and analysed at 8-month intervals. We evaluated the rates of cable externalization (CE), electrical failure (EF), and the interaction of these two complications. Structural lead failure was defined as radiographic CE. Oversensing of non-cardiac signal or sudden changes in impedance, sensing, or pacing thresholds constituted EF. RESULTS: During a mean follow-up of 10.2⯱â¯2.9 years, 16 patients (32%) died. We observed lead malfunction in 13 patients (26%): three (23%) due to CE, six (46%) to EF and four (31%) to both complications. Of the malfunctioning leads, 77% failed after seven years of follow-up. The incidence rate (IR) of overall malfunction per 100 patients per year was 0.9 during the first seven years post-implantation, increased to 7.0 after the 7th year and more than doubled (to 16.7) after 10 years. Beyond seven years post-implantation, IR per 100 patient-years increased in both EF and CE (from 0.6 to 5.6 vs. 0.3 to 4.2, respectively). Presence of CE was associated with a 4-fold increase in the proportion of EF. CONCLUSION: The incidence of Riata ICD lead malfunction, both for EF and CE, increased dramatically after seven years and then more than doubled after 10 years post-implantation.
ABSTRACT
AIMS: Late gadolinium enhancement cardiac magnetic resonance (LGE-CMR) may define left atrial (LA) anatomy and structural remodelling, and facilitate atrial fibrillation (AF) ablation. We aimed to assess the intra- and inter-observer reproducibility and agreement of LGE-CMR parameters with direct application to AF ablation techniques. METHODS AND RESULTS: One experienced and one non-experienced observer performed complete LGE-CMR data analysis twice, on different days, in 40 randomly selected LGE-CMR examinations [20 performed before ablation (pre-ablation) and 20 performed 3 months after ablation (post-ablation)]. Four additional observers (two experienced and two non-experienced) performed complete LGE-CMR data analysis in a subgroup of 30 patients (15 pre-ablation and 15 post-ablation). All LGE-CMR were performed in sinus rhythm. Intra- and inter-observer reproducibility of LA volume, LA area, and sphericity index (SI) was high: coefficient of variation <10% and intraclass correlation coefficient >0.71. Geometric congruency of repeated reconstruction of LA shape was high: maximal error <5 mm for intra-observer and <8 mm for inter-observer. The precision of scar location increased with extent of scar, and was high (Dice coefficient >0.75) when the scar area was >5 cm2 for a single observer and >15 cm2 for multiple observers. Non-experienced observers performed equally well to experienced observers. CONCLUSION: Late gadolinium enhancement cardiac magnetic resonance measurements of LA area, volume, and SI were reproducible, and geometric congruency of LA shape was high. Location of scar was precise for scar areas >5 cm2 for single observers and >15 cm2 for multiple observers, regardless of the observers' experience. These results may serve as a reference for future studies on the role for substrate-based AF ablation procedures.
