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. 2022 Aug 9;6(4):100078.
doi: 10.1016/j.shj.2022.100078. eCollection 2022 Aug.

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

Colin M Barker  1 , Christopher U Meduri  2 , Peter S Fail  3 , Jeffrey W Chambers  4 , Darrell J Solet  3 , Jacob M Kriegel  5 , Deborah C Vela  6 , Kari Feldt  2 , Thomas D Pate  7 , Avni P Patel  7 , Tamaz Shaburishvili  8
Affiliations

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

Colin M Barker et al. Struct Heart. .

Abstract

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 preclinical 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 patients 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.

Keywords: Heart failure; No-implant shunt; Preserved ejection fraction; Radiofrequency.

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Conflict of interest statement

C. M. Barker reports consulting fees from and is an advisory board/board member to Alleviant Medical. C. U. Meduri reports consulting fees from Alleviant Medical, Anteris Technologies, Boston Scientific, Medtronic, Vdyne, speakers’ fees from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic; he is an advisory board member for Anteris Technologies and Cardiovalve, and a proctor for Boston Scientific. P. S. Fail reports consulting fees from BioVentrix and Alleviant Medical, speakers’ fees from Abbott Vascular, Boston Scientific, and Medtronic, and served as principal investigator of research studies for Ancora Heart and Corvia Medical. J. W. Chambers reports consulting fees from Alleviant Medical and serves as Chief Medical Officer of Cardiovascular Systems Inc. D. J. Solet reports consulting fees from Abbott Medical and Alleviant Medical. J. M. Kriegel reports consulting fees from, is an advisory board/board member to, and serves as Chief Medical Officer of Alleviant Medical. K. Feldt reports consulting fees from Abbott Vascular, Alleviant Medical, Anteris Technologies, Pfizer Inc, and Orion Pharma. T. D. Pate and A. P. Patel are employed by Alleviant Medical. T. Shaburishvili served as principal investigator of a research study for Alleviant Medical. All other authors declare no competing interests.

Figures

Figure 1
Figure 1
Overview of the Alleviant procedure. (a) The tip of the device is advanced across the interatrial septum. (b) The tip of the device is opened to deploy the tissue anchoring mechanism within the LA. (c) The tip of the device is closed, thereby securing the target tissue, and a pulse of radiofrequency energy is applied to excise the tissue. Abbreviations: LA, left atrium; RA, right atrium.
Figure 2
Figure 2
Representative images of fresh interatrial shunt situated within the boundaries of the fossa ovalis across all timepoints (right atrial view). (a) Acute specimen shows the orifice edges appear rounded and expose the acutely sectioned tissue. (b) Thirty-day chronic shows surfaces of the shunt orifice edge and neighboring tissue appear smooth and glistening. (c) Sixty-day chronic shows a circular to mildly oval orifice with smooth edges.
Figure 3
Figure 3
Representative histologic sections across all timepoints. (a) Acutely cut posterior (left panel) and anterior (right panel) shunt edges present a tapered, rounded contour, with modest platelet/fibrin deposition in the anterior edge. A very thin band of coagulative changes (thermal effect) is also present in the myocardium adjacent to the cut (arrows, approximately 400 μm in depth). (b) Thirty-day shunt edges appeared rounded and fully healed, displaying fibrous remodeling and endothelialization. (c) Sixty-day sample (Movat) shows approximately 350 μm of collagen deposition at the rounded shunt edge, indicative of remodeling and normal healing. Stains: hematoxylin and eosin (top) and Movat (bottom); bar = 500 μm.
Figure 4
Figure 4
Representative images of 3D transesophageal echocardiographic assessment of interatrial shunt immediately following shunt creation in a human subject.
Figure 5
Figure 5
Representative images of transesophageal echocardiographic assessment of a human subject showing shunt patency sustained through 6-month follow-up. (a) Baseline, immediately post-shunt creation. (b) Six-month follow-up.
Figure 6
Figure 6
Representative images of cardiac computed tomography assessment showing shunt patency sustained through 6-month follow-up in a human subject. (a) Baseline, immediately postshunt creation. (b) Six-month follow-up.
See this image and copyright information in PMC

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