6.) Patient outcome at one-year follow-up
One-year follow-up was available in 103 out of the total of 190 treated patients (54.2%). The follow up was conducted as part of CIED interrogations, which amounted to 51.7% of the SR (n=46), 67.9% of the EL (n=19) and 51.2% of the SI group (n=38). In this context, non-irritating wound conditions were found in 94.7% (EL, SR) and 100% (SR), and generator pockets were irritation-free in 100% of all cases. In the three cases of irritating wound healing, the previous generator pocket with keloid formation or a superficial wound irritation was identified as source of discomfort. However, in no case further surgical measures were required. The new device implants demonstrated adequate device function in 100% of cases in the EL and SI groups, whereas two uncomplicated RV electrode revisions were necessary in the SR group due to loss of sensing (4.9%). Overall, all groups showed excellent lead parameter measurements after one year (Tab. 3).
Of particular interest was the final assessment of the treatment courses. The laboratory inflammatory parameters, LV-EF, and current NYHA class were again determined. It was found that the infection treatments in all groups were comparably effective and successfully completed (Fig. 1, left). However, all patients showed a comparable improvement in NYHA classes and a recovered or improved LV-EF at the end of treatment (Fig. 1, right). It is noteworthy that the LV-EF initially decreased in the two groups (SR/EL) without immediate implantation of a final system, while the heart function of the SI group continuously improved from the start of the intervention until the end of observation (Fig. 2).
Finally, the question arose regarding the number of lethal treatment courses. Using the social data, we were able to supplement the time interval between hospital discharge and the one-year follow-up, although we could unfortunately only determine the date of death and not the exact circumstances of death. One death (1.1%) occurred in the 8th postoperative month in the SR group, three (10.7%) occurred after one month and two months in the EL group, and two (2.7%) occurred after one and six months in the SI group. The overall mortality rates at 1 year were 3.4% (SR), 21.4% (EL), and 4.1% (SI), with the EL group having the significantly highest mortality rate of all treated groups (Table 3).