Advances on interatrial shunt therapy for heart failure

doi:10.3877/cma.j.issn.2095-6568.2024.01.010

Abstract

Ya Wang, Huayiyang Zou, Wei Sun. Advances on interatrial shunt therapy for heart failure[J]. Chinese Journal of Heart and Heart Rhythm(Electronic Edition), 2024, 12(01): 45-50.

/ / Recommend

Add to citation manager EndNote|Ris|BibTeX

URL: https://zhxzyxldzzz.cma-cmc.com.cn/EN/10.3877/cma.j.issn.2095-6568.2024.01.010

https://zhxzyxldzzz.cma-cmc.com.cn/EN/Y2024/V12/I01/45

Figures/Tables 2

References 27

[1]	Lawton JS, Tamis-Holland JE, Bangalore S, et al. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure[J]. J Card Fail,2022, 28(5):1-167.
[2]	Sidney S, Go AS, Jaffe MG, et al. Association between aging of the US population and heart disease mortality from 2011 to 2017[J]. JAMA Cardiol, 2019, 4(12):1280-1286.
[3]	廖玉华, 杨杰孚, 张健, 等. 舒张性心力衰竭诊断和治疗专家共识[J]. 临床心血管病杂志, 2020, 36(1):1-10.
[4]	Litwin SE, Borlaug BA, Komtebedde J, et al. Update on atrial shunt therapy for treatment of heart failure[J]. Struct Heart, 2022, 6(6):100090.
[5]	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.
[6]	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.
[7]	Di Tanna GL, Wirtz H, Burrows KL, et al. Evaluating risk prediction models for adults with heart failure: A systematic literature review[J]. PLoS One, 2020, 15(1):e0224135.
[8]	Feldman T, Mauri L, Kahwash R, et al. Transcatheter interatrial shunt device for the treatment of heart failure with preserved ejection fraction (REDUCE LAP-HF I [Reduce Elevated Left Atrial Pressure in Patients With Heart Failure]): a phase 2, randomized, sham-controlled trial[J]. Circulation, 2018, 137(4):364-375.
[9]	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 Failure II (REDUCE LAP-HF II)[J]. Am Heart J, 2020, 226:222-231.
[10]	Sun W, Zou H, Yong Y, et al. The RAISE trial: a novel device and first-in-man trial[J]. Circ Heart Fail, 2022, 15(4):e008362.
[11]	Griffin JM, Borlaug BA, Komtebedde J, et al. Impact of interatrial shunts on invasive hemodynamics and exercise tolerance in patients with heart failure[J]. J Am Heart Assoc, 2020, 9(17):e016760.
[12]	Søndergaard L, Reddy V, Kaye D, et al. Transcatheter treatment of heart failure with preserved or mildly reduced ejection fraction using a novel interatrial implant to lower left atrial pressure[J]. Eur J Heart Fail, 2014, 16(7):796-801.
[13]	Hasenfuss G, Gustafsson F, Kaye D, et al. Rationale and design of the reduce elevated left atrial pressure in patients with heart failure (Reduce LAP-HF) Trial[J]. J Card Fail, 2015, 21(7):594-600.
[14]	Kaye DM, Hasenfuß G, Neuzil P, et al. One-year outcomes after transcatheter insertion of an interatrial shunt device for the management of heart failure with preserved ejection fraction[J]. Circ Heart Fail, 2016, 9(12):e003662.
[15]	Feldman T, Komtebedde J, Burkhoff D, et al. Transcatheter interatrial shunt device for the treatment of heart failure: rationale and design of the randomized trial to REDUCE Elevated Left Atrial Pressure in Heart Failure (REDUCE LAP-HF I)[J]. Circ Heart Fail, 2016, 9(7):e003025.
[16]	Shah SJ, Feldman T, Ricciardi MJ, et al. One-year safety and clinical outcomes of a transcatheter interatrial shunt device for the treatment of heart failure with preserved ejection fraction in the reduce elevated left atrial pressure in patients with heart failure (REDUCE LAP-HF I) trial: a randomized clinical trial[J]. JAMA Cardiol, 2018, 3(10):968-977.
[17]	Shah SJ, Borlaug BA, Chung ES, et al. Atrial shunt device for heart failure with preserved and mildly reduced ejection fraction (REDUCE LAP-HF II): a randomised, multicentre, blinded, sham-controlled trial[J]. Lancet, 2022, 399(10330):1130-1140.
[18]	Shah SJ. Innovative clinical trial designs for precision medicine in heart failure with preserved ejection fraction[J]. J Cardiovasc Transl Res, 2017, 10(3):322-336.
[19]	Borlaug BA, Blair J, Bergmann MW, et al. Latent pulmonary vascular disease may alter the response to therapeutic strial shunt device in heart failure[J]. Circulation, 2022, 145(21):1592-1604.
[20]	Salah HM, Levin AP, Fudim M. Device therapy for heart failure with preserved ejection fraction[J]. Cardiol Clin, 2022, 40(4):507-515.
[21]	Rodés-Cabau J, Bernier M, Amat-Santos IJ, et al. Interatrial shunting for heart failure: early and late results from the first-in-human experience with the V-Wave system[J]. JACC Cardiovasc Interv, 2018, 11(22):2300-2310.
[22]	Del Trigo M, Bergeron S, Bernier M, et al. Unidirectional left-to-right interatrial shunting for treatment of patients with heart failure with reduced ejection fraction: a safety and proof-of-principle cohort study[J]. Lancet, 2016, 387(10025):1290-1297.
[23]	Guimarães 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.
[24]	Emani S, Burkhoff D, Lilly SM. Interatrial shunt devices for the treatment of heart failure[J]. Trends Cardiovasc Med, 2021, 31(7):427-432.
[25]	Bakhshaliyev N, Çelikkale İ, Enhoş A, et al. Impact of atrial flow regulator (AFR) implantation on 12-month mortality in heart failure : Insights from a single site in the PRELIEVE study[J]. Herz, 2022, 47(4):366-373.
[26]	Hibbert B, Zahr F, Simard T, et al. Left atrial to coronary sinus shunting for treatment of symptomatic heart failure[J]. JACC Cardiovasc Interv, 2023, 16(11):1369-1380.
[27]	van de Bovenkamp AA, Wijkstra N, Oosterveer FPT, et al. The value of passive leg raise during right heart catheterization in diagnosing heart failure with preserved ejection fraction[J]. Circ Heart Fail, 2022, 15(4):321-330.

装置	研究	研究设计（主要纳入标准）	例数	发表年份	时间跨度	主要疗效终点
IASD	探索性研究	单臂［LVEF＞45%，心功能Ⅱ~Ⅳ级（NYHA分级），静息PCWP＞15 mmHg或运动负荷下PCWP＞25 mmHg］	11	2014 2015	1个月 12个月	静息PCWP下降5 mmHg。心功能分级（NYHA）下降0.5；明尼苏达心衰评分下降29分；6 min步行距离增加32 m
	REDUCE LAP-HF	单臂［LVEF＞40%，心功能Ⅱ~Ⅳ级（NYHA分级），静息PCWP＞15 mmHg或运动负荷下PCWP＞25 mmHg］	64	2016	6个月	运动负荷下PCWP下降3mmHg；Qp/Qs 1.27；标准化峰值PCWP下降15 mmHg/W./kg
				2016	12个月	心功能分级（NYHA）中位下降1级；6 min步行距离增加32 m；明尼苏达心衰评分下降15分；年通畅率98.5%
				2018	36个月	年观察死亡率3.4/100；低于基线MAGGIC评分的10.2/100（P=0.02）
	REDUCE LAP-HF机制研究	随机、假手术对照、双盲［心功能Ⅲ/Ⅳ级（NYHA分级），LVEF≥40%，运动负荷下PCWP≥15mmHg］	44	2018	1个月	最大运动负荷下PCWP下降3 mmHg，标准化峰值PCWP下降
	REDUCE LAP-HF机制研究	随机、假手术对照、双盲［心功能Ⅲ/Ⅳ级（NYHA分级），LVEF≥40%，运动负荷下PCWP≥15mmHg］	44	2018	12个月	心衰年住院率下降67%（P=0.06）；心功能（NYHA分级）中位下降1级；6 min步行距离和KCCQ无变化；通畅率100%
V-Wave Gen 1	探索性研究	单臂［心功能Ⅲ/Ⅳ级（NYHA分级），LVEF≤40%，PCWP≥15mmHg］	10	2016	3个月	8/9心功能分级（NYHA分级）改善；杜克活动度状态改善11；KCCQ改善35分；步行距离增加74 m；PCWP下降6mmHg
V-Wave Gen 1	探索性研究	单臂［心功能Ⅲ/Ⅳ级（NYHA分级），LVEF＞15%，至少1次1年内因心衰再住院］	38	2018	12个月	62%患者心功能Ⅰ/Ⅱ级（NYHA分级）；73%KCCQ评级改善≥5分；步行距离增加28 m；PCWP、RAP或PAP没有显著改变；Qp/Qs为1.1；12个月时14%房间隔关闭，36%狭窄；分流患者血流动力学改善
V-Wave Gen 2	探索性研究	单臂［心功能Ⅲ/Ⅳ级（NYHA分级）］	6	2020	12个月	83%患者心功能Ⅰ/Ⅱ级（NYHA分级）；杜克活动状态改善15；KCCQ升高32分；6 min步行距离增加64 m；Qp/Qs为1.16
Occlutech AFR	AFR-PRELIEVE	单臂［心功能Ⅲ/Ⅳ级（NYHA分级）；LVEF≥15%］	34	2019	6个月	HFrEF/HFpEF，心功能（NYHA分级）下降1.4/1.1；KCCQ改善16分/20分；6 min步行距离增加30/26 m；PCWP下降2/5 mmHg；Qp/Qs为1.3/1.1
NoYa	RAISE trial	单臂	10	2022	6个月	分流口直径3～4mm；步行距离增加91 m；BNP下降2 186 pg/ml，6个月时3/10患者分流闭合
Alleviant	HF-1，HF-2， HFrEF	单臂	33（28例HFpEF，5例HFrEF）	2022		分流口直径7 mm；非植入型；6个月时100%分流；运动负荷下PCWP下降；6 min步行距离增加；随访进行中
Alt Flow	ALT FLOW	单臂	87	2023		6个月随访时，KCCQ改善23分，心功能（NYHA分级）改善，6 min步行距离提高36 m
IASD	REDUCE LAP-HF II	双盲随机对照试验（LVEF＞40%）	626	2022	5年	招募和2年随访完成。总体没有改善，但事后亚组分析提示PVR<1.74 WU组，心衰发生率降低50%，KCCQ改善42%（2年随访结果）
V-Wave	RELIEVE-HF	单臂（Roll-in）+随机对照（第二阶段），［Ⅱ~Ⅳa级（NYHA分级），HFrEF和HFpEF］	Roll-in组100例，后续随即对照纳入至500例			Roll-in组97例患者，招募于2022年10月完成。初步研究结果：安全性高，KCCQ和心功能（NYHA分级）改善，心脏结构良好重塑。

装置	研究	研究设计（主要纳入标准）	例数	发表年份	时间跨度	主要疗效终点
IASD	探索性研究	单臂［LVEF＞45%，心功能Ⅱ~Ⅳ级（NYHA分级），静息PCWP＞15 mmHg或运动负荷下PCWP＞25 mmHg］	11	2014 2015	1个月 12个月	静息PCWP下降5 mmHg。心功能分级（NYHA）下降0.5；明尼苏达心衰评分下降29分；6 min步行距离增加32 m
	REDUCE LAP-HF	单臂［LVEF＞40%，心功能Ⅱ~Ⅳ级（NYHA分级），静息PCWP＞15 mmHg或运动负荷下PCWP＞25 mmHg］	64	2016	6个月	运动负荷下PCWP下降3mmHg；Qp/Qs 1.27；标准化峰值PCWP下降15 mmHg/W./kg
				2016	12个月	心功能分级（NYHA）中位下降1级；6 min步行距离增加32 m；明尼苏达心衰评分下降15分；年通畅率98.5%
				2018	36个月	年观察死亡率3.4/100；低于基线MAGGIC评分的10.2/100（P=0.02）
	REDUCE LAP-HF机制研究	随机、假手术对照、双盲［心功能Ⅲ/Ⅳ级（NYHA分级），LVEF≥40%，运动负荷下PCWP≥15mmHg］	44	2018	1个月	最大运动负荷下PCWP下降3 mmHg，标准化峰值PCWP下降
	REDUCE LAP-HF机制研究	随机、假手术对照、双盲［心功能Ⅲ/Ⅳ级（NYHA分级），LVEF≥40%，运动负荷下PCWP≥15mmHg］	44	2018	12个月	心衰年住院率下降67%（P=0.06）；心功能（NYHA分级）中位下降1级；6 min步行距离和KCCQ无变化；通畅率100%
V-Wave Gen 1	探索性研究	单臂［心功能Ⅲ/Ⅳ级（NYHA分级），LVEF≤40%，PCWP≥15mmHg］	10	2016	3个月	8/9心功能分级（NYHA分级）改善；杜克活动度状态改善11；KCCQ改善35分；步行距离增加74 m；PCWP下降6mmHg
V-Wave Gen 1	探索性研究	单臂［心功能Ⅲ/Ⅳ级（NYHA分级），LVEF＞15%，至少1次1年内因心衰再住院］	38	2018	12个月	62%患者心功能Ⅰ/Ⅱ级（NYHA分级）；73%KCCQ评级改善≥5分；步行距离增加28 m；PCWP、RAP或PAP没有显著改变；Qp/Qs为1.1；12个月时14%房间隔关闭，36%狭窄；分流患者血流动力学改善
V-Wave Gen 2	探索性研究	单臂［心功能Ⅲ/Ⅳ级（NYHA分级）］	6	2020	12个月	83%患者心功能Ⅰ/Ⅱ级（NYHA分级）；杜克活动状态改善15；KCCQ升高32分；6 min步行距离增加64 m；Qp/Qs为1.16
Occlutech AFR	AFR-PRELIEVE	单臂［心功能Ⅲ/Ⅳ级（NYHA分级）；LVEF≥15%］	34	2019	6个月	HFrEF/HFpEF，心功能（NYHA分级）下降1.4/1.1；KCCQ改善16分/20分；6 min步行距离增加30/26 m；PCWP下降2/5 mmHg；Qp/Qs为1.3/1.1
NoYa	RAISE trial	单臂	10	2022	6个月	分流口直径3～4mm；步行距离增加91 m；BNP下降2 186 pg/ml，6个月时3/10患者分流闭合
Alleviant	HF-1，HF-2， HFrEF	单臂	33（28例HFpEF，5例HFrEF）	2022		分流口直径7 mm；非植入型；6个月时100%分流；运动负荷下PCWP下降；6 min步行距离增加；随访进行中
Alt Flow	ALT FLOW	单臂	87	2023		6个月随访时，KCCQ改善23分，心功能（NYHA分级）改善，6 min步行距离提高36 m
IASD	REDUCE LAP-HF II	双盲随机对照试验（LVEF＞40%）	626	2022	5年	招募和2年随访完成。总体没有改善，但事后亚组分析提示PVR<1.74 WU组，心衰发生率降低50%，KCCQ改善42%（2年随访结果）
V-Wave	RELIEVE-HF	单臂（Roll-in）+随机对照（第二阶段），［Ⅱ~Ⅳa级（NYHA分级），HFrEF和HFpEF］	Roll-in组100例，后续随即对照纳入至500例			Roll-in组97例患者，招募于2022年10月完成。初步研究结果：安全性高，KCCQ和心功能（NYHA分级）改善，心脏结构良好重塑。

Please choose a citation manager

Content to export

Advances on interatrial shunt therapy for heart failure

RichHTML

PDF (PC)

Knowledge

Cited

Abstract

Cite this article

share this article

Figures/Tables 2

References 27

Related Articles 0

Recommended Articles

Metrics

Comments

模态框（Modal）标题

Please choose a citation manager

Content to export

Advances on interatrial shunt therapy for heart failure

RichHTML

PDF (PC)

Knowledge

Cited

Abstract

Cite this article

share this article

Figures/Tables 2

References 27

Related Articles 0

Recommended Articles

Metrics

Comments