王义为,金屏,翟蒙恩,孟欣,李昱希,毛予,刘元章,杨剑,刘洋

• 1:中国人民解放军空军军医大学第一附属医院心血管外科
• 2:中国人民解放军空军军医大学第一附属医院超声科

摘要(Abstract)：

目的 评估单中心射血分数降低的心力衰竭（HFrEF）患者植入D-shant心房分流器的短期临床结果。方法 回顾性分析2022年1月至2023年1月入住中国人民解放军空军军医大学第一附属医院心血管外科的12例接受经皮植入D-shant的HFrEF患者。使用超声心动图评估心腔大小和心室功能，同时收集右心导管测量的数据和患者临床指标，并将术后12个月的随访数据与D-shant植入前所搜集的数据进行比较。研究的主要终点为随访期间发生的重大心脏、神经或肾不良事件。次要终点为功能状态的提升，包括心功能、生活质量和运动能力。结果 对12例患者都成功使用D-shant实施了经皮心房分流术。术后即刻透视和超声心动图证实所有患者的D-shant定位准确、血流通畅。术后血流动力学评估显示，平均肺毛细血管楔压显著下降[（29.8±3.4）mmHg比（17.8±0.8）mmHg,P<0.001]，差异有统计学意义。12个月随访时，累计不良事件发生率为8.3%（因1例患者接受心脏移植），左心房内径从（65.8±6.5）mm显著缩小至（48.0±4.5）mm(P<0.001)，差异有统计学意义。此外，临床心功能指标、患者的生活质量以及运动能力均有显著改善。结论 这项单中心研究发现，使用D-shant心房分流器对HFrEF患者实施经皮心房分流术是安全有效的。短期随访表明，分流管持续通畅，并且干预措施与改善功能状态相关。

关键词(KeyWords)： 射血分数降低的心力衰竭;经皮心房分流术;心房分流器;肺毛细血管楔压;D-shant

Abstract:

Keywords:

基金项目(Foundation): 国家重点研发计划项目（2022YFC2503402、2020YFC2008100）;; 陕西省创新能力支撑计划-科技创新团队项目（2020TD-034）;; 国家自然科学基金项目（82370375）;; 西京医院助推基金项目（XJZT24LY42）

作者(Author): 王义为,金屏,翟蒙恩,孟欣,李昱希,毛予,刘元章,杨剑,刘洋

参考文献(References)：

• [1] McMurray JJ,Packer M,Desai AS,et al. Angiotensinneprilysin inhibition versus enalapril in heart failure[J]. N Engl J Med,2014,371(11):993-1004. DOI:10.1056/NEJMoa1409077.
• [2] Swedberg K,Komajda M,B?hm M,et al. Ivabradine and outcomes in chronic heart failure(SHIFT):a randomised placebo-controlled study[J]. Lancet,2010,376(9744):875-885. DOI:10.1016/S0140-6736(10)61198-1.
• [3] Packer M,Anker SD,Butler J,et al. Cardiovascular and renal outcomes with empagliflozin in heart failure[J]. N Engl J Med,2020,383(15):1413-1424. DOI:10.1056/NEJMoa2022190.
• [4] Hasenfu?G,Hayward C,Burkhoff D,et al. A transcatheter intracardiac shunt device for heart failure with preserved ejection fraction(REDUCE LAP-HF):a multicentre,open-label,single-arm,phase 1 trial[J]. Lancet,2016,387(10025):1298-1304. DOI:10.1016/S0140-6736(16)00704-2.
• [5] Feldman T,Mauri L,Kahwash R,et al. Transcatheter interatrial shunt device for the treatment of heart failure with preserved ejection fraction(REDUCE LAP-HFⅠ[Reduce Elevated Left Atrial Pressure in Patients With Heart Failure]):a phase 2,randomized,sham-controlled trial[J]. Circulation,2018,137(4):364-375. DOI:10.1161/CIRCULATIONAHA.117.032094.
• [6] Shah SJ,Borlaug BA,Chung ES,et al. Atrial shunt device for heart failure with preserved and mildly reduced ejection fraction(REDUCE LAP-HFⅡ)：a randomised,multicentre,blinded,sham-controlled trial[J]. Lancet,2022,399(10330):1130-1140. DOI:10.1016/S0140-6736(22)00016-2.
• [7] Rodés-Cabau J,Bernier M,Amat-Santos IJ,et al. Interatrial shunting for heart failure:early and late results from the firstin-human experience with the V-Wave system[J]. JACC Cardiovasc Interv,2018,11(22):2300-2310. DOI:10.1016/j.jcin.2018.07.001.
• [8] Guimar?es L,Bergeron S,Bernier M,et al. Interatrial shunt with the second-generation V-Wave system for patients with advanced chronic heart failure[J]. EuroIntervention,2020,15(16):1426-1428. DOI:10.4244/EIJ-D-19-00291.
• [9] Ambrosy AP,Fonarow GC,Butler J,et al. The global health and economic burden of hospitalizations for heart failure:lessons learned from hospitalized heart failure registries[J]. J Am Coll Cardiol,2014,63(12):1123-1133. DOI:10.1016/j.jacc.2013.11.053.
• [10] Ong MK,Romano PS,Edgington S,et al. Effectiveness o f remote patient monitoring after discharge of hospitalized patients with heart failure:the better effectiveness after transition--heart failure(BEAT-HF)randomized clinical trial[J].JAMA Intern Med,2016,176(3):310-318. DOI:10.1001/jamainternmed.2015.7712.
• [11] Del Trigo M,Rodés-Cabau J. Transcatheter structural heart interventions for the treatment of chronic heart failure[J]. Circ Cardiovasc Interv,2015,8(7):e001943. DOI:10.1161/CIRCINTERVENTIONS.114.001943.
• [12] Guimaraes L,Lindenfeld J,Sandoval J,et al. Interatrial shunting for heart failure:current evidence and future perspectives[J]. EuroIntervention,2019,15(2):164-171.DOI:10.4244/EIJ-D-18-01211.
• [13]杨士伟，张薇，周玉杰.房间隔分流装置在心力衰竭介入治疗中的应用现状与前景[J].中国介入心脏病学杂志，2022,30(9):690-692.DOI:10.3969/j.issn.1004-8812.2022.09.009.
• [14] Shang X,Liu M,Zhong Y,et al. Clinical study on the treatment of chronic heart failure with a novel D-shant atrium shunt device[J]. ESC Heart Fail,2022,9(3):1713-1720. DOI:10.1002/ehf2.13842.
• [15] Hahn RT,Lerakis S,Delgado V,et al. Multimodality imaging of right heart function:JACC Scientific Statement[J]. J Am Coll Cardiol,2023,81(19):1954-1973. DOI:10.1016/j.jacc.2023.03.392.
• [16]刘燕青，周欣蓓，蔡尚郎.心房分流术治疗慢性心力衰竭的研究进展[J].中国介入心脏病学杂志，2019,27(9):526-528.DOI:10.3969/j.issn.1004-8812.2019.09.012.
• [17] Tromp J,Ouwerkerk W,van Veldhuisen DJ,et al. A systematic review and network meta-analysis of pharmacological treatment of heart failure with reduced ejection fraction[J]. JACC Heart Fail, 2022, 10(2):73-84. DOI:10.1016/j.jchf.2021.09.004.
• [18] Mosterd A,Hoes AW. Clinical epidemiology of heart failure[J]. Heart,2007,93(9):1137-1146. DOI:10.1136/hrt.2003.025270.
• [19] Berry N,Mauri L,Feldman T,et al. Transcatheter interatrial shunt device for the treatment of heart failure:rationale and design of the pivotal randomized trial to REDUCE Elevated Left Atrial Pressure in Patients with Heart FailureⅡ（REDUCE LAP-HFⅡ）[J]. Am Heart J,2020,226:222-231. DOI:10.1016/j.ahj.2019.10.015.
• [20] Kulkarni SS,Sakaria AK,Mahajan SK,et al. Lutembacher’s syndrome[J]. J Cardiovasc Dis Res,2012,3(2):179-181. DOI:10.4103/0975-3583.95381.
• [21] Yi T,Li M,Fan F,et al. Haemodynamic changes of interatrial shunting devices for heart failure:a systematic review and metaanalysis[J]. ESC Heart Fail,2022,9(3):1987-1995.DOI:10.1002/ehf2.13911.
• [22]中国医师协会心血管内科医师分会结构性心脏病专业委员会，中国医师协会心血管内科医师分会心力衰竭专业委员会，中国医师协会心血管外科医师分会结构性心脏病专业委员会，等.房间隔分流器治疗射血分数保留心力衰竭：中国专家认识和建议[J].中国介入心脏病学杂志，2020,28(12):661-666.DOI:10.3969/j.issn.1004-8812.2020.12.001.
• [23] Kaye D,Shah SJ,Borlaug BA,et al. Effects of an interatrial shunt on rest and exercise hemodynamics:results of a computer simulation in heart failure[J]. J Card Fail,2014,20(3):212-221. DOI:10.1016/j.cardfail.2014.01.005.
• [24] Nassif ME,Windsor SL,Tang F,et al. Dapagliflozin effects on biomarkers,symptoms,and functional status in patients with heart failure with reduced ejection fraction:the DEFINE-HF trial[J]. Circulation,2019,140(18):1463-1476. DOI:10.1161/CIRCULATIONAHA.119.042929.