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Percutaneous Atriotomy for Levoatrial-to-Coronary Sinus Shunting in Symptomatic Heart Failure: First-in-Human
Trevor Simard1, Marino Labinaz2, Firas Zahr3
1CAPITAL Research Group, Division of Cardiology, University of Ottawa Heart Institute, Ottawa, Ontario, Canada; Department of Cellular and Molecular Medicine, University of Ottawa, Ottawa, Ontario, Canada.
Insights
This study introduces a new percutaneous atriotomy technique for left atrial decompression in heart failure patients. The novel left atrial-to-coronary sinus shunt shows feasibility and improves clinical outcomes.
Area of Science:
- Cardiology
- Interventional Cardiology
- Medical Devices
Background:
- Elevated left atrial (LA) pressures are a key factor in heart failure symptoms.
- Current LA decompression strategies using interatrial septal shunts carry risks like right-to-left shunting and systemic embolization.
- Preserving the interatrial septum is crucial for other transcatheter interventions.
Purpose of the Study:
- To report the first-in-human experience of a novel percutaneous atriotomy technique for accessing the left atrium.
- To evaluate the feasibility and efficacy of a new left atrial (LA)-to-coronary sinus (CS) shunt for LA decompression.
- To assess clinical and hemodynamic improvements in patients with symptomatic heart failure receiving the novel shunt.
Main Methods:
- A multicenter, international compassionate use study involving patients with symptomatic heart failure.
- Percutaneous atriotomy was performed via the coronary sinus (CS) using the right internal jugular vein access.
- A novel LA-to-CS shunt device was deployed for LA decompression, with assessments of clinical, anatomic, and hemodynamic parameters.
Main Results:
- Percutaneous atriotomy and shunt deployment were successful in 8 out of 11 attempted cases.
- No major periprocedural adverse events were observed during the follow-up period (median 201 days).
- Significant improvements were noted: NYHA functional class improved to I or II in 87.5%, pulmonary capillary wedge pressure decreased by a median of 9 mm Hg, and sustained shunting was achieved.
Conclusions:
- The percutaneous atriotomy represents a novel and feasible approach for left atrial access in transcatheter cardiac interventions.
- The novel LA-to-CS shunt effectively decompress the left atrium, leading to significant clinical and hemodynamic benefits.
- This technique offers a promising alternative for LA decompression, potentially mitigating risks associated with traditional interatrial septal shunts.
Objectives:
Our study reports the first-in-human experience of a novel approach for left atrial access via the coronary sinus-the percutaneous atriotomy-which is used for left atrial decompression with a dedicated left atrial (LA)-to-coronary sinus (CS) shunt.
Background:
Elevated LA pressures contribute to heart failure symptoms, and targeted therapy with atrial shunt devices for LA decompression is an emerging strategy. Current devices reside in the interatrial septum, with risk for right-to-left shunting and systemic embolization. Moreover, preservation of the interatrial septum is imperative with an increasing number of left-sided transseptal transcatheter interventions.
Methods:
Patients with symptomatic heart failure underwent implantation in a multicenter, international compassionate experience. Clinical, anatomic, and hemodynamic parameters were assessed at baseline and follow-up. The right internal jugular vein enabled CS cannulation, followed by CS-to-LA puncture and balloon dilation of the LA wall, completing the percutaneous atriotomy. The novel shunt device was then deployed between the left atrium and CS, enabling LA decompression.
Results:
Percutaneous atriotomy was attempted in 11 patients, with success in 8; of these, all shunt deployments were successful. In follow-up (median 201 days; interquartile range [IQR]: 156 to 260 days) there were no major periprocedural adverse events, New York Heart Association functional class improved to I or II in 87.5%, pulmonary capillary wedge pressure was reduced (Δ -9 mm Hg; IQR: -9.5 to -8 mm Hg), and shunting was sustained (Δ Qp/Qs 0.25; IQR: 0.19 to 0.33).
Conclusions:
Our study reports the first-in-human experience of a novel approach for left-sided transcatheter cardiac interventions: the percutaneous atriotomy. This approach enabled the placement of a novel LA-to-CS shunt for LA decompression. The procedure is feasible and results in clinical and hemodynamic improvements.
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