Left atrial to coronary sinus shunting for treatment of heart failure with mildly reduced or preserved ejection fraction: The ALT FLOW Early Feasibility Study 1‐year results

Aims Patients with heart failure and mildly reduced or preserved ejection fraction have limited therapeutic options. The ALT‐FLOW Early Feasibility Study evaluated safety, haemodynamics and outcomes for the APTURE transcatheter shunt system, a novel left atrium to coronary sinus shunt in these patie...

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Published in:European journal of heart failure 2024-04, Vol.26 (4), p.1065-1077
Main Authors: Urey, Marcus A., Hibbert, Benjamin, Jorde, Ulrich, Eckman, Peter, Simard, Trevor, Labinaz, Marino, Nazer, Babak, Wiley, Mark, Gupta, Bhanu, Sauer, Andrew, Shah, Hirak, Sorajja, Paul, Pineda, Andres M., Missov, Emil, Mahmud, Ehtisham, Kahwash, Rami, Lilly, Scott, Latib, Azeem, Murthy, Sandhya, Fam, Neil, Garcia, Santiago, Chung, Eugene S., Klein, Liviu, Cheng, Richard, Houston, Brian A., Amoroso, Nicholas S., Chang, Lee, Gafoor, Sameer, Chaudhry, Sunit‐Preet, Hermiller, James, Schwartz, Jonathan G., Aldaia, Lillian, Koulogiannis, Konstantinos, Gray, William A., Zahr, Firas
Format: Article
Language:English
Subjects:
Atrial shunt
Heart failure
HFpEF
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Summary:Aims Patients with heart failure and mildly reduced or preserved ejection fraction have limited therapeutic options. The ALT‐FLOW Early Feasibility Study evaluated safety, haemodynamics and outcomes for the APTURE transcatheter shunt system, a novel left atrium to coronary sinus shunt in these patients. Methods and results Safety and shunt implantation success was evaluated for all 116 enrolled patients. An analysis population of implanted patients with a left ventricular ejection fraction (LVEF) >40% (n = 95) was chosen to assess efficacy via paired comparison between baseline and follow‐up haemodynamic (3 and 6 months), and echocardiographic, clinical and functional outcomes (6 months and 1 year). Health status and quality of life outcomes were assessed using the Kansas City Cardiomyopathy Questionnaire overall summary score (KCCQ‐OSS). The primary safety endpoint, major adverse cardiac, cerebral, and renal events, and reintervention through 30 days, occurred in 3/116 patients (2.6%). All implanted shunts were patent at 1 year. In patients with LVEF >40%, the mean (95% confidence interval) reduction in exercise pulmonary capillary wedge pressure (PCWP) at 20 W was −5.7 (−8.6, −2.9) mmHg at 6 months (p 
ISSN:1388-9842
1879-0844
1879-0844
DOI:10.1002/ejhf.3241