Perforating the GORE® CARDIOFORM septal occluder and atrial septal defect occluder to gain access to the left atrium.

OBJECTIVE: Perforate the expanded polytetrafluoroethylene membrane of the GORE® CARDIOFORM Septal Occluder (GSO) and GORE® CARDIOFORM ASD Occluder (GCA) after implantation. BACKGROUND: Percutaneous transseptal access to the left atrium is necessary for many structural and electrophysiological procedures. The potential need to access the left atrium may influence decision-making for patent foramen ovale or atrial septal defect closure. METHODS: Sixteen canines underwent implantation of equal number GSO or GCA devices. A transseptal crossing procedure was performed through the device 85 (±1) days postoccluder implantation. The crossing procedure was performed utilizing commercially available equipment: radiofrequency/SureFlex sheath and standard needle/Mullin's sheath. Progressive dilation of the perforation was performed to allow passage of a 12 French Mullin's sheath into the left atrium. RESULTS: Left atrial access was achieved in all cases. Postmortem analysis demonstrated passage through both occluder discs in all radiofrequency/SureFlex sheath cases (4 GSO, 4 GCA) and half of the standard needle/Mullin's sheath cases (3 GSO, 1 GCA). The remaining standard needle/Mullin's sheath cases demonstrated perforation through the right atrial disc but passage around the septal aspect of the left atrial disc, thus not perforating the left atrial disc. No acute embolic complications from the procedure were observed. CONCLUSIONS: Left atrial access may be achieved through the GSO or GCA devices after implantation and endothelialization. The combination of a radiofrequency needle and steerable sheath provides benefit over a standard needle and Mullin's sheath in accomplishing passage through both occluder discs.

Examining physiological and perceptual consequences of noise exposure.

The consequences of noise exposure on the auditory system are not entirely understood. In animals, noise exposure causes selective synaptopathy-an uncoupling of auditory nerve fibers from sensory cells-mostly in fibers that respond to high sound levels. Synaptopathy can be measured physiologically in animals, but a direct relationship between noise exposure and synaptopathy in humans has yet to be proven. Sources of variability, such as age, indirect measures of noise exposure, and comorbid auditory disorders, obfuscate attempts to find concrete relationships between noise exposure, synaptopathy, and perceptual consequences. This study adds to the ongoing effort by examining relationships between noise exposure, auditory brainstem response (ABR) amplitudes, and speech perception in adults of various ages and audiometric thresholds and a subset of younger adults with clinically normal hearing. Regression models including noise exposure, age, hearing thresholds, and sex as covariates were compared to find a best-fitting model of toneburst ABR wave I amplitude at two frequencies and word recognition performance in three listening conditions: background noise, time compression, and time compression with reverberation. The data suggest the possibility of detecting synaptopathy in younger adults using physiological measures, but that age and comorbid hearing disorders may hinder attempts to assess noise-induced synaptopathy.