Author + information
- Trevor Simard, MDa,b,
- Marino Labinaz, MDa,
- Firas Zahr, MDc,
- Babak Nazer, MDc,
- William Gray, MDd,
- James Hermiller, MDe,
- Sunit-Preet Chaudhry, MDe,
- Leonardo Guimaraes, MDf,
- François Philippon, MDf,
- Peter Eckman, MDg,
- Josep Rodés-Cabau, MDf,
- Paul Sorajja, MDg and
- Benjamin Hibbert, MD PhDa,b,∗ ()
- aCAPITAL Research Group, Division of Cardiology, University of Ottawa Heart Institute, Ottawa, Ontario, Canada
- bDepartment of Cellular and Molecular Medicine, University of Ottawa, Ottawa, Ontario, Canada
- cKnight Cardiovascular Institute, Oregon Health & Science University, Portland, Oregon
- dLankenau Heart Institute, Main Line Health System, Wynnewood, Pennsylvania
- eSt. Vincent Medical Group, St. Vincent Heart Center, Indianapolis, Indiana
- fQuebec Heart & Lung Institute, Laval University, Quebec City, Quebec, Canada
- gValve Science Center, Minneapolis Heart Institute Foundation at Abbott Northwestern Hospital, Minneapolis, Minnesota
- ↵∗Address for correspondence:
Dr. Benjamin Hibbert, University of Ottawa Heart Institute, 40 Ruskin Street, Room H4238, Ottawa, Ontario K1Y 4W7, Canada.
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.
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.
The authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the JACC: Cardiovascular Interventions author instructions page.
- Received February 12, 2020.
- Accepted February 18, 2020.
- 2020 The Authors