TY - JOUR
T1 - Percutaneous Atriotomy for Levoatrial–to–Coronary Sinus Shunting in Symptomatic Heart Failure
T2 - First-in-Human Experience
AU - Simard, Trevor
AU - Labinaz, Marino
AU - Zahr, Firas
AU - Nazer, Babak
AU - Gray, William
AU - Hermiller, James
AU - Chaudhry, Sunit Preet
AU - Guimaraes, Leonardo
AU - Philippon, François
AU - Eckman, Peter
AU - Rodés-Cabau, Josep
AU - Sorajja, Paul
AU - Hibbert, Benjamin
N1 - Funding Information:
Dr. Zahr has received research and educational grants from Edwards Lifesciences. Dr. Rodés-Cabau is a consultant for V-Wave; and has received institutional research grants from Edwards Lifesciences. Dr. Sorajja is a consultant for Edwards Lifesciences. Dr. Hibbert has conducted research work for Edwards Lifesciences. Edwards Lifesciences provided the devices and clinical support for implantation procedures. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
Publisher Copyright:
© 2020 The Authors
PY - 2020/5/25
Y1 - 2020/5/25
N2 - 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.
AB - 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.
KW - coronary sinus
KW - heart failure
KW - left-atrial shunting
KW - levoatrial
KW - percutaneous atriotomy
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U2 - 10.1016/j.jcin.2020.02.022
DO - 10.1016/j.jcin.2020.02.022
M3 - Article
C2 - 32438996
AN - SCOPUS:85084366013
SN - 1936-8798
VL - 13
SP - 1236
EP - 1247
JO - JACC: Cardiovascular Interventions
JF - JACC: Cardiovascular Interventions
IS - 10
ER -