OR13-2
No-implant Interatrial Shunt for Heart Failure with Preserved and Mildly-reduced Ejection Fraction: Twelve-month Outcomes from Multi-center ALLEVIATE Feasibility Studies
Presenter
Binita Shah, M.D., FSCAI, NYU Grossman School of Medicine, New York, NY
Binita Shah, M.D., FSCAI1, James E. Udelson, M.D.2, Colin M. Barker, MD, FSCAI3, Gerard Wilkins4, Benjamin Wilkins5, Robert Gooley6, Siobahn Lockwood6, Brian J Potter, M.D.7, Christopher Meduri, M.D.8, Peter S. Fail, M.D., FSCAI9, Darrell Solet9, Kari Feldt, M.D.10, Jacob Kriegel11 and Tamaz Shaburishvili12, (1)NYU Grossman School of Medicine, New York, NY, (2)Tufts Medical Center, Boston, MA, (3)Vanderbilt University Medical Center, Nashville, TN, (4)Mercy Hospital, Dunedin, SA, Australia, (5)Dunedin Public Hospital, Dunedin, New Zealand, (6)MonashHeart, Clayton, VIC, Australia, (7)CHUM, Westmount, QC, Canada, (8)Karolinska Institutet, Stockholm, Sweden, (9)Cardiovascular Institute of the South, Houma, LA, (10)Karolinska University Hospital, Stockholm, Sweden, (11)Alleviant Medical, New York, NY, (12)Tbilisi Heart and Vascular Clinic, Tbilisi, Georgia
Keywords: Heart Failure and Structural Heart Disease (SHD)
Background
Interatrial shunt procedures currently under clinical evaluation to treat refractory heart failure require a permanent device implant to maintain patency. The Alleviant device percutaneously excises interatrial septal tissue using a pulse of RF energy and does not require a permanent implant to maintain patency.
Methods
Ambulatory patients ≥ 40 years old with NYHA class ≥ II, LVEF ≥ 40% and elevated PCWP during supine ergometry were included in the ALLEVIATE-HF-1 and HF-2 studies. Femoral venous access and standard transseptal techniques were employed. The Alleviant System was used to create a shunt under fluoroscopic and echo guidance. In both studies, assessments included a repeat exercise hemodynamic study at 1 month with echo and biomarker evaluation through 12 months. The HF-2 study further included NYHA, KCCQ and 6MWT assessments through 12 months. Here we report 12-month data, adding longer duration of follow-up to a prior 6-month report.
Results
Of the 28 patients enrolled, 68% were female (mean age 68 years ± 9 years). Baseline resting and peak exercise mean PCWP were 19 ± 6 and 39 ± 10 mmHg, respectively. All procedures were successful with confirmation of left-to-right flow (mean shunt diameter 7.1 ± 0.9 mm) and no procedural adverse events observed. At 1-month, peak exercise PCWP decreased by a mean of 5.6 ± 7.9 mmHg (p=0.002) with no change in RA pressure. Through 12 months, there was no HF mortality or serious device or procedure-related adverse events through 12 months. KCCQ overall summary score increased 21 ± 22 points (p=0.01); NT-proBNP decreased 428 ± 601 pg/ml (p=0.008). There were no significant changes in 6MWT distance, or right atrial or ventricular size or function parameters at 12 months. Shunt patency was confirmed in all patients with evaluable echocardiograms, with Qp:Qs 1.2 ± 0.2 at 12 months, indicative of left-to-right flow.
Conclusions
In these uncontrolled first-in-human studies of a no-implant interatrial shunt for HFpEF/HFmrEF, shunts were stable in patency and size with favorable safety and efficacy signals. The results show promise for this new approach to treating heart failure with an appropriate hemodynamic profile. A randomized sham-controlled pivotal trial (ALLAY-HF) is currently underway.