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Transcatheter Interatrial Shunt Device Treatment for HFpEF
Study Questions:
What are the 1-year safety and clinical outcomes of the interatrial shunt device (IASD) compared with a sham control treatment for patients with heart failure with preserved ejection fraction (HFpEF)?
Methods:
The REDUCE LAP-HF I trial investigators conducted a phase 2, double-blind, 1-to-1 sham-controlled multicenter randomized clinical trial of IASD implantation versus a sham procedure (femoral venous access and imaging of the interatrial septum without IASD) in 22 centers in the United States, Europe, and Australia on patients with New York Heart Association (NYHA) class III or ambulatory class IV HF, left ventricular EF (LVEF) ≥40%, exercise pulmonary capillary wedge pressure (PCWP) ≥25 mm Hg, and PCWP-right atrial pressure gradient ≥5 mm Hg. Safety was assessed by major adverse cardiac, cerebrovascular, or renal events (MACCRE). Exploratory outcomes evaluated at 1 year were hospitalizations for HF, NYHA class, quality of life, a 6-minute walk test (6MWT), and device patency.
Results:
After 1 year, shunts were patent in all IASD-treated patients; MACCRE did not differ significantly in the IASD arm (2 of 21 [9.5%]) versus the control arm (5 of 22 [22.7%]; p = 0.41), and no strokes occurred. The yearly rate of hospitalizations for HF was 0.22 in the IASD arm and 0.63 in the control arm (p = 0.06). Median improvement in NYHA class was 1 class in the IASD arm (interquartile range [IQR], −1 to 0) versus 0 in the control arm (IQR, −1 to 0; p = 0.08). Quality of life and 6-minute walk test distance were similar in both groups. At 6 months, there was an increase in right ventricular size in the IASD arm (mean [standard deviation], 7.9 [8.0] ml/m2) versus the control arm (−1.8 [9.6] ml/m2; p = 0.002), consistent with left-to-right shunting through the device; no further increase occurred in the IASD arm at 12 months.
Conclusions:
The authors concluded that through 1 year of follow-up, IASD treatment appears safe, with no significant differences in MACCRE in patients receiving IASD compared with those who received sham control treatment.
Perspective:
This study reports that the IASD remained patent with left-to-right shunt flow in all patients, and was safe compared with a sham control procedure through 1 year of follow-up. Furthermore, the IASD-treated patients had similar HF hospitalization rates, NYHA class, quality-of-life measures (via the Kansas City Cardiomyopathy Questionnaire and EuroQol 5-Dimension scale), and exercise capacity, as measured by the 6MWT distance. Although these results are promising with regard to safety, a larger study is indicated to assess the clinical efficacy of the IASD in HFpEF patients. The ongoing REDUCE LAP-HF TRIAL II (NCT03088033) will provide additional insight when completed.
Keywords: ESC Congress, ESC18, Atrial Pressure, Atrial Septum, Cardiomyopathies, Diagnostic Imaging, Heart Failure, Primary Prevention, Pulmonary Wedge Pressure, Quality of Life, Renal Insufficiency, Stroke Volume, Treatment Outcome, Vascular Diseases
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