Wachter Rolf, Halbach Marcel, Bakris George L, Bisognano John D, Haller Hermann, Beige Joachim, Kroon Abraham A, Nadim Mitra K, Lovett Eric G, Schafer Jill E, de Leeuw Peter W
Clinic for Cardiology and Pneumology, German Center for Cardiovascular Research (DZHK), University of Göttingen, Göttingen, Germany.
Department of Internal Medicine III, Heart Center, University of Cologne, Cologne, Germany.
J Am Soc Hypertens. 2017 Feb;11(2):81-91. doi: 10.1016/j.jash.2016.12.003. Epub 2016 Dec 16.
Baroreflex activation therapy (BAT) is a device-based therapy for patients with treatment-resistant hypertension. In a randomized, controlled trial, the first-generation system significantly reduced blood pressure (BP) versus sham. Although an open-label validation study of the second-generation system demonstrated similar BP reductions, controlled data are not presently available. Therefore, this investigation compares results of first- and second-generation BAT systems. Two cohorts of first-generation BAT system patients were generated with propensity matching to compare against the validation group of 30 second-generation subjects. The first cohort was drawn from the first-generation randomized trial sham group and the second cohort from the active therapy group. Safety and efficacy were compared for the second-generation group relative to the first generation. At 6 months, second-generation BAT outperformed first-generation sham systolic BP reduction by 20 ± 28 mm Hg (mean ± standard deviation, P = .008), while BP reduction in first- and second-generation active groups was similar. At 12 months, efficacy was comparable between all three groups after the sham group had received 6 months of therapy; 47% of second-generation patients achieved goal systolic BP of 140 mm Hg or less after 12 months, comparable to 50% of patients at goal in the first-generation group (P > .999). Implant procedure time, system/procedural safety, and pulse generator longevity improved with the second-generation system. Propensity-matched cohort analysis of the first- and second-generation BAT systems suggests similar therapeutic benefit and superior BP reduction of the second-generation system relative to sham control. Implantation procedure duration and perioperative safety were improved with the second-generation device. These findings should be validated in a prospective randomized trial.
压力反射激活疗法（BAT）是一种针对难治性高血压患者的基于设备的疗法。在一项随机对照试验中，第一代系统与假手术组相比能显著降低血压（BP）。尽管对第二代系统的一项开放标签验证研究显示了类似的血压降低效果，但目前尚无对照数据。因此，本研究比较了第一代和第二代BAT系统的结果。通过倾向匹配生成了两组第一代BAT系统患者，以与30名第二代受试者的验证组进行比较。第一组来自第一代随机试验的假手术组，第二组来自积极治疗组。比较了第二代组相对于第一代组的安全性和有效性。在6个月时，第二代BAT在收缩压降低方面比第一代假手术组高出20±28 mmHg（均值±标准差，P = 0.008），而第一代和第二代积极治疗组的血压降低情况相似。在12个月时，假手术组接受6个月治疗后，三组的疗效相当；12个月后，47%的第二代患者实现了收缩压目标值140 mmHg或更低，与第一代组中达到目标的患者比例50%相当（P > 0.999）。第二代系统在植入手术时间、系统/手术安全性和脉冲发生器寿命方面有所改善。对第一代和第二代BAT系统进行倾向匹配队列分析表明，第二代系统相对于假手术对照具有相似的治疗益处和更好的血压降低效果。第二代设备缩短了植入手术持续时间并提高了围手术期安全性。这些发现应在前瞻性随机试验中得到验证。
