1426 EuroIntervention 2020;15: 1426-1428 published online August 2019 DOI: 10.4244/EIJ-D-19-00291 SHORT REPORT INTERVENTIONS FOR VALVULAR DISEASE AND HEART FAILURE © Europa Digital & Publishing 2020. All rights reserved. *Corresponding author: Quebec Heart & Lung Institute, Laval University, 2725 Chemin Ste-Foy, Quebec City, QC G1V 4GS, Canada. E-mail: josep.rodes@criucpq.ulaval.ca Interatrial shunt with the second-generation V-Wave system for patients with advanced chronic heart failure Leonardo Guimarães 1 , MD; Sebastien Bergeron 1 , MD; Mathieu Bernier 1 , MD; Tania Rodriguez-Gabella 1 , MD; David del Val 1 , MD; Philippe Pibarot 1 , PhD; Neal Eigler 2 , MD; William T. Abraham 2,3 , MD; Josep Rodés-Cabau 1 *, MD 1. Quebec Heart and Lung Institute, Laval University, Quebec City, Quebec, Canada; 2. V-Wave, Caesarea, Israel; 3. Division of Cardiovascular Medicine, The Ohio State University, Columbus, OH, USA This paper also includes supplementary data published online at: https://eurointervention.pcronline.com/doi/10.4244/EIJ-D-19-00291 Introduction Left atrial decompression by creating an interatrial shunt has been associated with significant improvements in functional status and quality of life in patients with heart failure (HF) with reduced and preserved left ventricular ejection fraction (HFrEF, HFpEF) 1 . The initial experience with the V-Wave shunt (V-Wave Ltd, Caesarea, Israel) showed its safety and preliminary efficacy for treating patients with HFrEF and HFpEF 2,3 . However, shunt nar- rowing/occlusion was observed in up to 50% of the patients at 12-month follow-up, secondary to early valve degeneration 3 . Following this initial experience, modifications were implemented in order to improve late device patency and continued efficacy, with valve removal being the most relevant feature of the newer (second) generation of the V-Wave shunt (Figure 1). The present study reports the first-in-human experience with the second gen- eration of the V-Wave shunt in patients with advanced chronic HF. Methods A total of 10 patients underwent an interatrial shunting procedure with the second-generation V-Wave shunt between September and November 2017 at the Quebec Heart & Lung Institute. Patients had a history of chronic HF and New York Heart Association (NYHA) Class ≥III despite optimal tolerated drug and device therapies as defined by American College of Cardiology(ACC)/ American Heart Association (AHA) guidelines. PROCEDURES Supplementary Figure 1 illustrates the main steps of V-Wave implantation. Following the procedure, patients received dual anti- platelet therapy (aspirin plus clopidogrel) for three months, and aspirin indefinitely. Those patients receiving anticoagulation ther- apy pre-procedure continued with the same anticoagulation regime post procedure. FOLLOW-UP Patients were followed in an HF clinic at 1, 3, 6 and 12 months. Transthoracic echocardiography (TTE) was performed at each clinical visit; if the shunt was not properly visualised, trans- oesophageal echocardiography (TEE) was performed. Assessments of functional status, quality of life and laboratory tests were also performed during each follow-up visit. OUTCOMES Clinical outcomes included major adverse cardiovascular and neu- rological events (MACNE), and HF hospitalisation. STATISTICAL ANALYSIS Categorical variables are reported as number (percent) and continu- ous variables as mean±SD. Changes in continuous variables were analysed using the paired t-test or Wilcoxon signed-rank test, as appropriate. Categorical variables were compared with the SUBMITTED ON 20/03/2019 - REVISION RECEIVED ON 1 st 09/06/2019 / 2 nd 26/07/2019 - ACCEPTED ON 14/08/2019