经导管主动脉瓣置换术及亚临床瓣叶血栓形成对低风险患者的影响：LRT试验4年结果
Transcatheter Aortic Valve Replacement and Impact of Subclinical Leaflet Thrombosis in Low-Risk Patients: LRT Trial 4-Year Outcomes.
作者信息
Waksman Ron, Bhogal Sukhdeep, Gordon Paul, Ehsan Afshin, Wilson Sean R, Levitt Robert, Parikh Puja, Bilfinger Thomas, Hanna Nicholas, Buchbinder Maurice, Asch Federico M, Kim Francis Y, Weissman Gaby, Ben-Dor Itsik, Shults Christian C, Ali Syed, Sutton Joseph A, Shea Corey, Zhang Cheng, Garcia-Garcia Hector M, Satler Lowell F, Rogers Toby
机构信息
Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC (R.W., S.B., I.B.-D., S.A., J.A.S., C.S., C.Z., H.M.G.-G., L.F.S., T.R.).
Division of Cardiology, Miriam Hospital, Providence, RI (P.G.).
出版信息
Circ Cardiovasc Interv. 2023 May;16(5):e012655. doi: 10.1161/CIRCINTERVENTIONS.122.012655. Epub 2023 May 16.
BACKGROUND
The LRT trial (Low-Risk Transcatheter Aortic Valve Replacement [TAVR]) demonstrated the safety and feasibility of TAVR in low-risk patients, with excellent 1- and 2-year outcomes. The objective of the current study is to provide the overall clinical outcomes and the impact of 30-day hypoattenuated leaflet thickening (HALT) on structural valve deterioration at 4 years.
METHODS
The prospective, multicenter LRT trial was the first Food and Drug Administration-approved investigational device exemption study to evaluate feasibility and safety of TAVR in low-risk patients with symptomatic severe tricuspid aortic stenosis. Clinical outcomes and valve hemodynamics were documented annually through 4 years.
RESULTS
A total of 200 patients were enrolled, and follow-up was available on 177 patients at 4 years. The rates of all-cause mortality and cardiovascular death were 11.9% and 3.3%, respectively. The stroke rate rose from 0.5% at 30 days to 7.5% at 4 years, and permanent pacemaker implantation rose from 6.5% at 30 days to 11.7% at 4 years. Endocarditis was detected in 2.5% of the cohort, with no new cases reported between 2 and 4 years. Transcatheter heart valve hemodynamics remained excellent post-procedure and were maintained (mean gradient 12.56±5.54 mm Hg and aortic valve area 1.69±0.52 cm) at 4 years. At 30 days, HALT was observed in 14% of subjects who received a balloon-expandable transcatheter heart valve. There was no difference in valve hemodynamics between patients with and without HALT (mean gradient 14.94±5.01 mm Hg versus 12.3±5.57 mm Hg; =0.23) at 4 years. The overall rate of structural valve deterioration was 5.8%, and there was no impact of HALT on valve hemodynamics, endocarditis, or stroke at 4 years.
CONCLUSIONS
TAVR in low-risk patients with symptomatic severe tricuspid aortic stenosis was found to be safe and durable at 4 years. Structural valve deterioration rates were low irrespective of the type of valve, and the presence of HALT at 30 days did not affect structural valve deterioration, transcatheter valve hemodynamics, and stroke rate at 4 years.
REGISTRATION
URL: https://www.
CLINICALTRIALS
gov; Unique identifier: NCT02628899.
背景
LRT试验（低风险经导管主动脉瓣置换术[TAVR]）证明了TAVR在低风险患者中的安全性和可行性，1年和2年的预后良好。本研究的目的是提供总体临床结局以及30天低密度瓣叶增厚（HALT）对4年时瓣膜结构退变的影响。
方法
前瞻性、多中心LRT试验是首个获得美国食品药品监督管理局批准的研究器械豁免研究，旨在评估TAVR在有症状的严重三尖瓣主动脉瓣狭窄低风险患者中的可行性和安全性。每年记录临床结局和瓣膜血流动力学情况，持续4年。
结果
共纳入200例患者，4年时对177例患者进行了随访。全因死亡率和心血管死亡率分别为11.9%和3.3%。卒中发生率从30天时的0.5%升至4年时的7.5%，永久性起搏器植入率从30天时的6.5%升至4年时的11.7%。队列中2.5%的患者检测到心内膜炎，2至4年期间未报告新病例。经导管心脏瓣膜血流动力学在术后仍保持良好，并在4年时维持（平均压差12.56±5.54 mmHg，主动脉瓣面积1.69±0.52 cm）。30天时，接受球囊扩张式经导管心脏瓣膜的患者中有14%观察到HALT。4年时，有HALT和无HALT的患者瓣膜血流动力学无差异（平均压差分别为14.94±5.01 mmHg和12.3±5.57 mmHg；P = 0.23）。瓣膜结构退变的总体发生率为5.8%，30天HALT的存在对4年时的瓣膜血流动力学、心内膜炎或卒中无影响。
结论
有症状的严重三尖瓣主动脉瓣狭窄低风险患者接受TAVR治疗4年时被发现是安全且持久的。无论瓣膜类型如何，瓣膜结构退变率都很低，30天出现HALT并不影响4年时的瓣膜结构退变、经导管瓣膜血流动力学和卒中发生率。
注册
网址：https://www.
临床试验
gov；唯一标识符：NCT02628899。
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