OBJECTIVE: The purpose of this report was to describe the prespecified long-term safety objective of Micra at 12 months and electrical performance through 24 months.
METHODS: The Micra Transcatheter Pacing Study was a prospective single-arm study designed to assess the safety and efficacy of the Micra VVIR leadless/intracardiac pacemaker. Enrolled patients met class I or II guideline recommendations for de novo ventricular pacing. The long-term safety objective was freedom from a system- or procedure-related major complication at 12 months. A predefined historical control group of 2667 patients with transvenous pacemakers was used to compare major complication rates.
RESULTS: The long-term safety objective was achieved with a freedom from major complication rate of 96.0% at 12 months (95% confidence interval 94.2%-97.2%; P < .0001 vs performance goal). The risk of major complications for patients with Micra (N = 726) was 48% lower than that for patients with transvenous systems through 12 months postimplant (hazard ratio 0.52; 95% confidence interval 0.35-0.77; P = .001). Across subgroups of age, sex, and comorbidities, Micra reduced the risk of major complications compared to transvenous systems. Electrical performance was excellent through 24 months, with a projected battery longevity of 12.1 years.
CONCLUSION: Long-term performance of the Micra transcatheter pacemaker remains consistent with previously reported data. Few patients experienced major complications through 12 months of follow-up, and all patient subgroups benefited as compared to transvenous pacemaker historical control group.
METHODS: Between November 2005 and November 2006, the technique was applied in 18 patients (6 female, 12 male; median age 50 years, range 16 - 73 years) on continuous ambulatory peritoneal dialysis with catheter malfunction secondary to omental wrap. Pneumoperitoneum was induced under general anesthesia. Three ports were inserted. The catheter was released from the omentum and repositioned in the pelvis. The omentum was then folded onto itself in a cephalad direction using silk sutures. This shortened the omentum. The risk of catheter migration was minimized with a polypropylene sling passed through the abdominal wall and around the catheter, then knotted subcutaneously. The sling allowed catheter removal without a new laparoscopy. The outcomes were prospectively evaluated.
RESULTS: Median operating time was 90 minutes (range 35 - 160 minutes). Adhesiolysis was performed in 4 patients: 1 patient had port-site leakage of dialysate, which settled with abdominal rest; 1 patient had bleeding during adhesiolysis and laparoscopic hemostasis was successful; 1 patient had recurrent catheter obstruction 2 weeks post-operatively and was converted to hemodialysis; and 1 patient had recurrent malfunction secondary to small bowel wrap after 5.5 months; re-salvage was successful. The success rate of the first salvage procedure was 89%(16/18). The catheters were still functioning after a mean follow-up of 16.5 +/- 6.3 months (range 0.5 - 24 months). The 1-year catheter survival rate was 83.3%.
CONCLUSIONS: Omental folding is a safe and effective technique for salvaging peritoneal dialysis catheters.