University of Otago, Christchurch, New Zealand.
Circulation. 2010 Mar 9;121(9):1086-95. doi: 10.1161/CIRCULATIONAHA.108.800490. Epub 2010 Feb 22.
Previous studies suggest that management of ambulatory hemodynamics may improve outcomes in chronic heart failure. We conducted a prospective, observational, first-in-human study of a physician-directed patient self-management system targeting left atrial pressure.
Forty patients with reduced or preserved left ventricular ejection fraction and a history of New York Heart Association class III or IV heart failure and acute decompensation were implanted with an investigational left atrial pressure monitor, and readings were acquired twice daily. For the first 3 months, patients and clinicians were blinded as to these readings, and treatment continued per usual clinical assessment. Thereafter, left atrial pressure and individualized therapy instructions guided by these pressures were disclosed to the patient. Event-free survival was determined over a median follow-up of 25 months (range 3 to 38 months). Survival without decompensation was 61% at 3 years, and events tended to be less frequent after the first 3 months (hazard ratio 0.16 [95% confidence interval 0.04 to 0.68], P=0.012). Mean daily left atrial pressure fell from 17.6 mm Hg (95% confidence interval 15.8 to 19.4 mm Hg) in the first 3 months to 14.8 mm Hg (95% confidence interval 13.0 to 16.6 mm Hg; P=0.003) during pressure-guided therapy. The frequency of elevated readings (>25 mm Hg) was reduced by 67% (P<0.001). There were improvements in New York Heart Association class (-0.7+/-0.8, P<0.001) and left ventricular ejection fraction (7+/-10%, P<0.001). Doses of angiotensin-converting enzyme/angiotensin-receptor blockers and beta-blockers were uptitrated by 37% (P<0.001) and 40% (P<0.001), respectively, whereas doses of loop diuretics fell by 27% (P=0.15).
Physician-directed patient self-management of left atrial pressure has the potential to improve hemodynamics, symptoms, and outcomes in advanced heart failure. Clinical Trial Registration Information- URL: http://www.clinicaltrials.gov. Unique identifier: NCT00547729.
先前的研究表明，对门诊血液动力学的管理可能会改善慢性心力衰竭的预后。我们进行了一项前瞻性、观察性、针对左心房压力的医师指导患者自我管理系统的首次人体研究。
40 名射血分数降低或保留、纽约心脏协会（NYHA）心功能 III 或 IV 级和急性失代偿史的患者植入了一个研究用左心房压力监测器，并每天两次采集读数。在前 3 个月，患者和临床医生对这些读数均不知情，治疗仍根据常规临床评估进行。此后，向患者公开左心房压力和根据这些压力制定的个体化治疗建议。中位随访 25 个月（范围 3 至 38 个月）后，确定无事件生存率。3 年时无失代偿生存率为 61%，并且在最初 3 个月后事件发生频率趋于降低（风险比 0.16 [95%置信区间 0.04 至 0.68]，P=0.012）。在压力指导治疗期间，平均每日左心房压力从前 3 个月的 17.6mmHg（95%置信区间 15.8 至 19.4mmHg）降至 14.8mmHg（95%置信区间 13.0 至 16.6mmHg；P=0.003）。>25mmHg 的读数频率降低了 67%（P<0.001）。纽约心脏协会（NYHA）心功能分级（-0.7+/-0.8，P<0.001）和左心室射血分数（7+/-10%，P<0.001）均有改善。血管紧张素转换酶/血管紧张素受体阻滞剂和β受体阻滞剂的剂量分别上调了 37%（P<0.001）和 40%（P<0.001），而袢利尿剂的剂量下降了 27%（P=0.15）。
医师指导的患者自我管理左心房压力有可能改善晚期心力衰竭患者的血液动力学、症状和预后。
临床试验注册信息- URL：http://www.clinicaltrials.gov。唯一标识符：NCT00547729。
