Keteyian Steven J, Isaac Debra, Thadani Udho, Roy Brad A, Bensimhon Daniel R, McKelvie Robert, Russell Stuart D, Hellkamp Anne S, Kraus William E
Division of Cardiovascular Medicine, Henry Ford Hospital, Detroit, MI, USA.
Am Heart J. 2009 Oct;158(4 Suppl):S72-7. doi: 10.1016/j.ahj.2009.07.014.
To assess the safety of symptom-limited exercise testing in patients with New York Heart Association class II-IV heart failure symptoms due to left ventricular systolic dysfunction, we investigated the frequency of all-cause fatal and nonfatal major cardiovascular (CV) events among subjects enrolled in a prospective clinical trial (HF-ACTION). We hypothesized that exercise testing would be safe, as defined by a rate for all-cause death of <0.1 per 1,000 tests and a rate of nonfatal CV events <1.0 per 1,000 tests.
Before enrollment and at 3, 12, and 24 months after randomization, subjects were scheduled to complete a symptom-limited graded exercise test with open-circuit spirometry for analysis of expired gases. To ensure the accurate reporting of exercise test-related events, we report deaths and nonfatal major CV events per 1,000 tests at months 3, 12, or 24 after randomization.
A total of 2,331 subjects were randomized into HF-ACTION. After randomization, 2,037 subjects completed 4,411 exercise tests. There were no test-related deaths, exacerbation of heart failure or angina requiring hospitalization, myocardial infarctions, strokes, or transient ischemic attacks. There was one episode each of ventricular fibrillation and sustained ventricular tachycardia. There were no exercise test-related implantable cardioverter defibrillator discharges requiring hospitalization. These findings correspond to zero deaths per 1,000 exercise tests and 0.45 nonfatal major CV events per 1,000 exercise tests (95% CI 0.11-1.81).
In New York Heart Association class II-IV patients with severe left ventricular systolic dysfunction, we observed that symptom-limited exercise testing is safe based on no deaths and a rate of nonfatal major CV events that is <0.5 per 1,000 tests.
为评估纽约心脏协会II-IV级因左心室收缩功能障碍出现心力衰竭症状的患者进行症状限制性运动试验的安全性,我们调查了一项前瞻性临床试验(心力衰竭-运动训练改善临床结局试验,HF-ACTION)受试者中全因死亡和非致死性重大心血管(CV)事件的发生频率。我们假设运动试验是安全的,全因死亡率<每1000次试验0.1例,非致死性CV事件发生率<每1000次试验1.0例。
在入选前以及随机分组后3、12和24个月,受试者计划完成一次症状限制性分级运动试验,采用开路肺量计分析呼出气体。为确保准确报告运动试验相关事件,我们报告随机分组后3、12或24个月时每1000次试验的死亡和非致死性重大CV事件。
共有2331名受试者被随机分组至HF-ACTION。随机分组后,2037名受试者完成了4411次运动试验。没有与试验相关的死亡、需要住院治疗的心力衰竭或心绞痛加重、心肌梗死、中风或短暂性脑缺血发作。有1例室颤和1例持续性室性心动过速。没有与运动试验相关的需要住院治疗的植入式心脏复律除颤器放电。这些结果相当于每1000次运动试验死亡0例,每1000次运动试验非致死性重大CV事件0.45例(95%可信区间0.11-1.81)。
在纽约心脏协会II-IV级严重左心室收缩功能障碍患者中,我们观察到基于无死亡以及非致死性重大CV事件发生率<每1000次试验0.5例,症状限制性运动试验是安全的。