左室电极导线Attain汇总ppt课件.pptVIP

The following slide presents a comparison of key safety data. The Model 4195 exhibits the highest rate of implant success, 94.4%, and the lowest rate of dislodgement complications. As the first-ever active fixation left-heart lead for cardiac resynchronization therapy (CRT), the Attain StarFix lead demonstrates a zero percent dislodgement rate after one day post implant. Overall, including all data post implant, the lead has a low 0.7 percent chronic dislodgement rate. These dislodgement rates are supported by one of the industry’s largest and longest-running left-heart lead clinical studies involving 385 implants followed for up to four years. Traditional passive fixation left-heart leads, where there is no active mechanism to fix the lead in place, show average dislodgement rates of 2-8 percent based on several published clinical studies. In terms of dislodgement, there were 3 events in the Model 4195 study. Two occurred in the first five implants (2/5). At that point placement recommendations were established. The 3rd dislodgement occurred in a case where one of the recommendations was not followed, however the investigator did not feel there was another transvenous option for the patient and was willing to take the risk of dislodgement. The only value that was less favorable was the phrenic nerve complication rate. One possible explanation is that in having a higher success rate, some patients who wouldn’t have received another type of lead due to phrenic nerve stimulation (at the site where the lead would be wedged), were perhaps able to be implanted, but the location of the lead still placed them at risk. It is important to note that no 4195 related dissections or perforations were reported during the clinical study. Dislodgement Notes For the Model 4195 clinical study, an event was adjudicated as being a dislodgement when visual movement was confirmed by x-ray or fluoro. Dislodgement percentages do not include loss of capture or exit block. The 3 dislodgeme