Kings College Hospital, Cardiac Catheter Suite, Level 1, Denmark Hill, SE5 9RS London, UK.
Europace. 2010 Jun;12(6):811-6. doi: 10.1093/europace/euq053. Epub 2010 Mar 14.
The Secura ICD and Consulta CRT-D are the first defibrillators to have automatic right atrial (RA), right ventricular (RV), and left ventricular (LV) capture management (CM). Complete CM was evaluated in an implantable cardioverter defibrillator (ICD) population.
Two prospective clinical studies were conducted in 28 centres in Europe and Israel. Automatic CM data were compared with manual threshold measurements, the CM applicability was determined, and adjustments to pacing outputs were analysed. In total, 160 patients [age 64.6 +/- 10.4 years, 77% male, 80 ICD and 80 cardiac resynchronization therapy defibrillator (CRT-D)] were included. The differences between automatic and manual measurements were </=0.25 V in 97% (RA CM) and 96% (RV CM) and were all within the safety margin. Fully automatic CM measurements were available within 1 week prior to the 3-month visit in 90% (RA), 99% (RV), and 97% (LV) of the patients. Results indicated increased output (threshold >2.5 V) due to raised RA threshold in seven (4.4%), high RV threshold in nine (5.6%), and high LV threshold in three patients (3.8%). All high threshold detections and all automatic modulations of pacing output were adjudicated appropriate.
Complete CM adjusts pacing output appropriately, permitting a reduction in office visits while it may maximize device longevity. The study was registered at ClinicalTrials.gov identifiers: NCT00526227 and NCT00526162.
Secura ICD 和 Consulta CRT-D 是首批具有自动右心房(RA)、右心室(RV)和左心室(LV)捕获管理(CM)功能的除颤器。在植入式心脏复律除颤器(ICD)人群中评估了完全 CM。
在欧洲和以色列的 28 个中心进行了两项前瞻性临床研究。将自动 CM 数据与手动阈值测量进行了比较,确定了 CM 的适用性,并分析了对起搏输出的调整。共纳入 160 例患者[年龄 64.6±10.4 岁,77%为男性,80 例 ICD 和 80 例心脏再同步治疗除颤器(CRT-D)]。RA CM 和 RV CM 的自动和手动测量值差异均在 0.25 V 以内,分别为 97%和 96%,均在安全范围内。在 3 个月就诊前的 1 周内,90%(RA)、99%(RV)和 97%(LV)的患者可获得全自动 CM 测量值。结果表明,由于 RA 阈值升高,7 例(4.4%)患者输出增加(阈值>2.5 V),9 例(5.6%)患者 RV 阈值升高,3 例(3.8%)患者 LV 阈值升高。所有高阈值检测和所有自动调节起搏输出均被认为是合适的。
完全 CM 适当地调整起搏输出,减少了就诊次数,同时可能最大限度地延长设备的使用寿命。该研究在 ClinicalTrials.gov 上注册了标识符:NCT00526227 和 NCT00526162。