These difficulties are more likely to be encoun- tered in patients with limited venous access such as patients with ESRD. In a study of 27 patients with ESRD, the subcutaneous implantable car- dioverter-defibrillator was not associated with an increased risk of procedural complications or The risk of infection appears to be lower with subcutaneous implant- able cardioverter-defibrillators than with transve- Therefore, a subcutaneous CLINICAL STATEMENTS AND GUIDELINES implantable cardioverter-defibrillator may be pre- ferred in patients who are at high risk of infec- tion, such as those with a prior device infection, ESRD, diabetes mellitus, or who are chronically immunosuppressed. 2. Nonrandomized studies show that the subcu- taneous implantable cardioverter-defibrillator reliably detects and converts VF during defibril- lation threshold testing and successfully termi- nates spontaneous sustained VT that occurs In 1 study of 314 patients, the 180-day complication-free rate was 99%, and the success of VF termination with first shock was >90%.S11.1-2 All spontaneous epi- sodes of VT/VF recorded in 21 patients (6.7%) were successfully converted, and there were no lead failures, endocarditis or bacteremia, tam- ponade, cardiac perforation, pneumothorax, or hemothorax associated with the subcutaneous patients enrolled in the EFFORTLESS (Evaluation of Factors Impacting Clinical Outcome and Cost Effectiveness of the S-ICD) registry,S11.1-3 the com- plication-free rate was 94%, at 360 days. First shock conversion efficacy was 88% with 100% overall successful clinical conversion after a maxi- mum of 5 shocks. In 882 patients enrolled in investigational device exemption trials and the 111 spontaneous VT/ VF events were treated in 59 patients; 90.1% were terminated with 1 shock, and 98.2% were terminated within the 5 available shocks. The estimated 3-year inappropriate shock rate was 13.1% most due to oversensing of cardiac sig- nals, and mortality was 4.7%. Device-related complications occurred in 11.1% of patients. 