p.77 抽出テキスト
September 25, 2018 Circulation. 2018;138:e272–e391. DOI: 10.1161/CIR.0000000000000549 e348 CLINICAL STATEMENTS AND GUIDELINES implantable cardioverter-defibrillator may be preferred in patients who are at high risk of infection, such as those with a prior device infection, ESRD, diabetes mellitus, or who are chronically immunosuppressed. 2. Nonrandomized studies show that the subcutaneous implantable cardioverter-defibrillator reliably detects and converts VF during defibrillation threshold testing and successfully terminates spontaneous sustained VT that occurs during follow-up.S11.1-1,S11.1-13 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 episodes of VT/VF recorded in 21 patients (6.7%) were successfully converted, and there were no lead failures, endocarditis or bacteremia, tamponade, cardiac perforation, pneumothorax, or hemothorax associated with the subcutaneous implantable cardioverter-defibrillator.S11.1-2 In 472 patients enrolled in the EFFORTLESS (Evaluation of Factors Impacting Clinical Outcome and Cost Effectiveness of the S-ICD) registry,S11.1-3 the complication-free rate was 94%, at 360 days. First shock conversion efficacy was 88% with 100% overall successful clinical conversion after a maximum of 5 shocks. In 882 patients enrolled in investigational device exemption trials and the EFFORTLESS registry,S11.1-4 111 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 signals, and mortality was 4.7%. Device-related complications occurred in 11.1% of patients. An ongoing trial will compare the effect of the subcutaneous implantable cardioverter-defibrillator with that of the transvenous ICD on the outcomes of inappropriate shocks, complications, shock efficacy, and mortality.S11.1-13 3. The subcutaneous implantable cardioverterdefibrillator is incapable of bradycardia pacing, biventricular pacing, or antitachycardia pacing. Therefore, patients who need any of these types of pacing from an ICD should not be offered a subcutaneous implantable cardioverterdefibrillator.S11.1-6 Some clinical scenarios may come up in which a transvenous pacemaker for bradycardia pacing in a patient with a subcutaneous implantable cardioverter-defibrillator which is needed; this can be performed as long as the pacing is not unipolar. Leadless pacing devices for patients who require bradycardia pacing will be evaluated with the subcutaneous implantable cardioverter-defibrillator in the near future. 11.2 Wearable Cardioverter-Defibrillator Recommendations for Wearable Cardioverter-Defibrillator References that support the recommendations are summarized in Online Data Supplement 56. COR LOE Recommendations IIa B-NR 1. In patients with an ICD and a history of SCA or sustained VA in whom removal of the ICD is required (as with infection), the wearable cardioverter-defibrillator is reasonable for the prevention of SCD.S11.2-1–S11.2-4 IIb B-NR 2. In patients at an increased risk of SCD but who are not ineligible for an ICD, such as awaiting cardiac transplant, having an LVEF of 35% or less and are within 40 days from an MI, or have newly diagnosed NICM, revascularization within the past 90 days, myocarditis or secondary cardiomyopathy or a systemic infection, the wearable cardioverter-defibrillator may be reasonable.S11.2-1–S11.2-5 Synopsis The wearable cardioverter-defibrillator is a vestlike device worn under the clothing that continuously monitors the heart rhythm and automatically delivers an electric shock when VF or VT is detected. This device is intended to be worn continuously, 24 hours per day, except when the wearer is bathing or showering. The wearable cardioverter-defibrillator has been approved in the United States by the US Food and Drug Administration for patients who are “at risk for SCA and are not candidates for or refuse an implantable defibrillator.”S11.2-6 A science advisory from the AHA summarizes the data and recommendations for the use of the wearable cardioverter-defibrillator.S11.2-4 Effectiveness of the wearable cardioverter-defibrillator in recognition and defibrillation of VF has been demonstrated in a number of studies, although no RCTs support the use of the wearable cardioverter-defibrillator. Among 3569 patients who received the device for various reasons, for at least 1 day in the US manufacturer registry, there were 80 VT/VF events in 59 patients, with a frequency of 1.7% per patient-year. First shock efficacy was 99%, with postshock survival of 90%. Overall, 2% of the patients received an inappropriate shock.S11.2-1 Recommendation-Specific Supportive Text 1. Removal of an ICD for a period of time, most commonly due to infection, exposes the patient to risk of untreated VT/SCD unless monitoring and access to emergency external defibrillation is maintained. In 1 series of 354 patients who received the wearable cardioverter-defibrillator, the indication was infection in 10%.S11.2-3 For patients with a history of SCA or sustained VA, Downloaded from http://ahajournals.org by on October 7, 2026