Feasibility of a No-Implant Approach to Interatrial Shunts: Preclinical and Early Clinical Studies

被引:8
作者
Barker, Colin M. [1 ]
Meduri, Christopher U. [2 ]
Fail, Peter S. [3 ]
Chambers, Jeffrey W. [4 ]
Solet, Darrell J. [3 ]
Kriegel, Jacob M. [5 ]
Vela, Deborah C. [6 ]
Feldt, Kari [2 ]
Pate, Thomas D. [7 ]
Patel, Avni P. [7 ]
Shaburishvili, Tamaz [8 ]
机构
[1] Vanderbilt Univ, Sect Intervent Cardiol, Med Ctr, Nashville, TN USA
[2] Karolinska Univ Hosp, Dept Cardiol, Stockholm, Sweden
[3] Cardiovasc Inst South, Houma, LA USA
[4] Metropolitan Heart & Vasc Inst, Coon Rapids, MN USA
[5] Columbia Univ Irving Med Ctr, Dept Surg, New York, NY USA
[6] Texas Heart Inst, Cardiovasc Pathol, Houston, TX 77025 USA
[7] Alleviant Med, Austin, TX USA
[8] Tbilisi Heart & Vasc Clin, Tbilisi, Georgia
来源
STRUCTURAL HEART-THE JOURNAL OF THE HEART TEAM | 2022年 / 6卷 / 04期
基金
美国国家卫生研究院;
关键词
Heart failure; No -implant shunt; Preserved ejection fraction; Radiofrequency; REDUCED EJECTION FRACTION; LEFT ATRIAL PRESSURE; HEART-FAILURE; DEVICE;
D O I
10.1016/j.shj.2022.100078
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Background: Heart failure with preserved ejection fraction represents a major unmet clinical need with limited treatment options. Recent device therapies under investigation have focused on decompression of the left atrium through an implantable interatrial shunt. Although these devices have shown favorable safety and efficacy signals, an implant is required to maintain shunt patency, which may increase the patient risk profile and complicate subsequent interventions requiring transseptal access. Methods: The Alleviant System is a no-implant approach to creating an interatrial shunt using radiofrequency energy to securely capture, excise, and extract a precise disk of tissue from the interatrial septum. Acute pre -clinical studies in healthy swine (n = 5) demonstrated the feasibility of the Alleviant System to repeatably create a 7 mm interatrial orifice with minimal collateral thermal effect and minimal platelet and fibrin deposition observed histologically. Results: Chronic animal studies (n = 9) were carried out to 30-and 60-day time points and exhibited sustained shunt patency with histology demonstrating completely healed margins, endothelialization, and no trauma to adjacent atrial tissue. Preliminary clinical safety and feasibility were validated in a first-in-human study in pa-tients with heart failure with preserved ejection fraction (n = 15). All patients demonstrated shunt patency by transesophageal echocardiographic imaging at 1, 3, and 6 months, as well as cardiac computed tomography imaging at 6-month follow-up timepoints. Conclusions: Combined, these data support the safety and feasibility of a novel no-implant approach to creating an interatrial shunt using the Alleviant System. Continued follow-up and subsequent clinical studies are currently ongoing.
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收藏
页数:7
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