Five-Year Clinical and Quality of Life Outcomes From the CoreValve US Pivotal Extreme Risk Trial.

Suzanne V Arnold, George Petrossian, Michael J Reardon, Neal S Kleiman, Steven J Yakubov, Kaijun Wang, James Hermiller, J Kevin Harrison, G Michael Deeb, Jian Huang, David J Cohen
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引用次数: 5

Abstract

Background: Older adults with comorbidities who are at extreme risk for surgical aortic valve replacement may be appropriate candidates for transcatheter aortic valve replacement (TAVR). We present the 5-year clinical, echocardiographic, and health status outcomes of such patients treated with CoreValve self-expanding supra-annular TAVR.

Methods: The CoreValve US Extreme Risk Pivotal Trial was a prospective, nonrandomized, single-arm clinical trial of TAVR at 41 sites in the United States. The primary outcome was all-cause mortality or major stroke. Secondary outcomes included echocardiographic parameters and patient-reported health status, assessed with the Kansas City Cardiomyopathy Questionnaire.

Results: Between February 2011 and August 2012, 639 patients with severe aortic stenosis at extreme surgical risk underwent attempted TAVR (mean age 82.8±8.4 years, 53% women, mean Society of Thoracic Surgeons Predicted Risk of Mortality 10.4±5.6%, 77% iliofemoral access). The 5-year Kaplan-Meier rate of death or major stroke was 72.6% ([95% CI, 68.4%–76.7%]; death 71.6%, major stroke 11.5%), with no significant differences according to access site. Among patients who survived 5 years, mean transvalvular gradient was 7.5±5.9 mm Hg, and 3.1% had moderate or severe aortic regurgitation. Health status measures improved significantly by 1 month after TAVR through 1 year (mean change in Kansas City Cardiomyopathy Questionnaire–Overall Summary score 24.8 points [95% CI, 22.4–27.2]). Beyond 1 year, the Kansas City Cardiomyopathy Questionnaire–Overall Summary score decreased gradually but remained significantly improved from pre-TAVR through 5 years of follow-up among surviving patients (mean change from baseline, 14.3 points [95% CI, 10.7–17.9]).

Conclusions: Patients with severe aortic stenosis at extreme surgical risk who are treated with self-expanding supra-annular TAVR have high 5-year mortality. However, the short-term benefits of TAVR in terms of valve hemodynamics and quality of life are mostly preserved among surviving patients at 5 years, thereby supporting the continued use of TAVR in these challenging patients.

Registration: https://www.clinicaltrials.gov; Unique identifier: NCT01240902.

来自CoreValve美国枢纽极端风险试验的5年临床和生活质量结果
背景:有合并症的老年人,手术主动脉瓣置换术的风险极高,可能是经导管主动脉瓣置换术(TAVR)的合适人选。我们报告了这些患者接受CoreValve自扩式环上TAVR治疗的5年临床、超声心动图和健康状况结果。方法:CoreValve美国极端风险关键试验是一项前瞻性、非随机、单臂TAVR临床试验,在美国41个地点进行。主要结局是全因死亡率或主要中风。次要结果包括超声心动图参数和患者报告的健康状况,用堪萨斯城心肌病问卷进行评估。结果:2011年2月至2012年8月期间,639例有极高手术风险的严重主动脉瓣狭窄患者尝试了TAVR(平均年龄82.8±8.4岁,53%为女性,平均胸外科学会预测死亡风险10.4±5.6%,髂股通道77%)。5年Kaplan-Meier死亡率或重度卒中发生率为72.6% ([95% CI, 68.4%-76.7%];死亡71.6%,严重中风11.5%),不同访问地点无显著差异。在存活5年的患者中,平均经瓣梯度为7.5±5.9 mm Hg, 3.1%有中度或重度主动脉反流。TAVR后1个月,健康状况指标在1年内显著改善(堪萨斯城心肌病问卷-总体总结评分平均变化24.8分[95% CI, 22.4-27.2])。1年后,存活患者的堪萨斯城心肌病问卷-总体总结评分逐渐下降,但在随访5年期间,与tavr前相比仍有显著改善(与基线相比平均变化14.3分[95% CI, 10.7-17.9])。结论:有极高手术风险的严重主动脉瓣狭窄患者采用自扩式环上TAVR治疗,其5年死亡率较高。然而,在存活5年的患者中,TAVR在瓣膜血流动力学和生活质量方面的短期益处大多得以保留,因此支持在这些具有挑战性的患者中继续使用TAVR。注册:https://www.clinicaltrials.gov;唯一标识符:NCT01240902。
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