Department of Cardiothoracic and Vascular Surgery, Deutsches Herzzentrum Berlin (DZHB), Augustenburger Platz 1, 13353 Berlin, Germany.
Department for Cardiovascular Surgery, Charité Berlin, Chariteplatz 1, 10117 Berlin, Germany.
Eur Heart J. 2017 Dec 1;38(45):3359-3366. doi: 10.1093/eurheartj/ehx297.
RESPOND is a prospective, open-label, single-arm study evaluating the outcomes following transcatheter aortic valve implantation (TAVI) with the repositionable and fully retrievable Lotus Valve used in routine clinical practice for the treatment of patients with aortic valve stenosis.
RESPOND enrolled 1014 patients at sites across Europe, New Zealand, and Latin America; 996 patients received a Lotus Valve (mean age: 80.8 years; 50.8% female; Society of Thoracic Surgeons score: 6.0 ± 6.9). Repositioning was attempted in 29.2% of patients, with 99% success. The rate of all-cause mortality in the intent-to-treat population at 30 days (primary endpoint) was 2.6% (P < 0.001 vs. pre-specified performance goal). Thirty-day clinical follow-up was completed for 97.3% of patients. Among patients who received a Lotus Valve, the 30-day overall and disabling stroke rates were 3.0% and 2.2%, respectively. The 30-day permanent pacemaker implantation rate was 30.0% in all patients, and 34.6% in pacemaker-naïve patients. Echocardiographic data at baseline and pre-discharge were assessed by an independent core laboratory. Mean aortic valve gradient declined from 37.7 ± 15.2 mmHg at baseline to 10.8 ± 4.6 mmHg at hospital discharge (P < 0.001). Aortic valve area increased from 0.7 ± 0.2 cm2 at baseline to 1.8 ± 0.4 cm2 at discharge (P < 0.001). At hospital discharge, paravalvular leak (PVL) was absent or trace in 92% of patients; no patients had severe PVL, 0.3% of patients exhibited moderate PVL, and 7.7% of patients had mild PVL. Clinical follow-up in RESPOND will extend to 5 years.
The results of RESPOND confirm the safety and efficacy of TAVI with the Lotus Valve in routine clinical practice.
ClinicalTrials.gov #NCT 02031302.
RESPOND 是一项前瞻性、开放标签、单臂研究，评估了在常规临床实践中使用可重定位和完全可回收的 Lotus 瓣膜进行经导管主动脉瓣置换术（TAVI）后的结果，用于治疗主动脉瓣狭窄患者。
RESPOND 在欧洲、新西兰和拉丁美洲的多个地点招募了 1014 名患者；996 名患者接受了 Lotus 瓣膜治疗（平均年龄：80.8 岁；50.8%为女性；胸外科医生协会评分：6.0±6.9）。在 29.2%的患者中尝试了重新定位，成功率为 99%。意向治疗人群在 30 天（主要终点）的全因死亡率为 2.6%（P<0.001 与预先指定的性能目标相比）。97.3%的患者完成了 30 天的临床随访。在接受 Lotus 瓣膜治疗的患者中，30 天的总卒中发生率和致残性卒中发生率分别为 3.0%和 2.2%。所有患者的 30 天永久性起搏器植入率为 30.0%，起搏器初治患者为 34.6%。基线和出院前的超声心动图数据由独立的核心实验室评估。平均主动脉瓣跨瓣压差从基线时的 37.7±15.2mmHg 降至出院时的 10.8±4.6mmHg（P<0.001）。主动脉瓣面积从基线时的 0.7±0.2cm2增加至出院时的 1.8±0.4cm2（P<0.001）。出院时，92%的患者无或微量瓣周漏；无患者发生严重瓣周漏，0.3%的患者发生中度瓣周漏，7.7%的患者发生轻度瓣周漏。RESPOND 的临床随访将延长至 5 年。
RESPOND 的结果证实了在常规临床实践中使用 Lotus 瓣膜进行 TAVI 的安全性和有效性。
ClinicalTrials.gov #NCT 02031302。
