Log in to MyACC
No-Implant Interatrial Shunt for HFpEF Patients
Quick Takes
- This pilot feasibility study reports initial signals of safety and efficacy of the no-implant approach to creating an interatrial shunt.
- At the 6-month follow-up visit, there was a significant reduction in pulmonary capillary wedge pressure from baseline to 1 month, with promising clinical efficacy signals and no serious adverse events.
- Rigorously controlled and adequately powered randomized trials are needed to confirm safety and efficacy of this approach prior to clinical application.
Study Questions:
What is the safety and efficacy of a no-implant interatrial shunt for patients with heart failure with preserved ejection fraction (HFpEF) and heart failure with mildly reduced ejection fraction (HFmrEF)?
Methods:
The investigators conducted a multicenter, uncontrolled study of HFpEF/HFmrEF patients with New York Heart Association functional class ≥II, EF >40%, and pulmonary capillary wedge pressure (PCWP) during supine exercise ≥25 mm Hg with PCWP-to-right atrial (RA) gradient ≥5 mm Hg. Follow-up was through 6 months with imaging to assess shunt durability. The primary efficacy endpoint was the change in supine exercise PCWP at peak exercise from baseline to 1 month. The primary safety endpoint of the trial was the composite incidence of major adverse cardiac, cerebrovascular, and thromboembolic events defined as cardiovascular death, embolic stroke, embolic myocardial infarction, pulmonary or arterial embolism, and device-related and/or procedure-related serious adverse cardiac events.
Results:
A total of 28 patients were enrolled: 68% female, aged 68 ± 9 years. Baseline resting and peak exercise PCWP were 19 ± 7 and 40 ± 11 mm Hg, respectively. All procedures demonstrated technical success with confirmation of left-to-right flow (shunt diameter 7.1 ± 0.9 mm). At 1 month, peak exercise PCWP decreased 5.4 ± 9.6 mm Hg (p = 0.011) with no change in RA pressure. There were no serious device or procedure-related adverse events through 6 months. Six-minute walk distance increased 101 ± 71 meters (p < 0.001); Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score increased 26 ± 19 points (p < 0.001); N-terminal pro–B-type natriuretic peptide decreased 372 ± 857 pg/mL (p = 0.018); shunt patency was confirmed with unchanged diameter.
Conclusions:
The authors report that in these feasibility studies of a no-implant interatrial shunt for HFpEF/HFmrEF patients, shunts demonstrated stability with favorable safety and early efficacy signals.
Perspective:
This pilot feasibility study reports initial signals of safety and efficacy of the no-implant approach to creating an interatrial shunt. At the 6-month follow-up visit, there was a significant reduction in PCWP from baseline to 1 month, with promising clinical efficacy signals and no serious adverse events. While these results show promise toward a new minimally invasive method to treat patients with HF with preserved or mildly reduced EF, rigorously controlled and adequately powered randomized trials are needed to confirm safety and efficacy of this approach. Of note, no interatrial shunt system has shown benefit in a large randomized trial to date, including the adequately powered pivotal trial (REDUCE LAP-HF II), which reported neutral results of longer-term outcomes including cardiovascular death, HF hospitalization, and KCCQ score.
Clinical Topics: Diabetes and Cardiometabolic Disease, Heart Failure and Cardiomyopathies, Prevention, Vascular Medicine, Acute Heart Failure, Heart Failure and Cardiac Biomarkers, Exercise
Keywords: Embolic Stroke, Embolism, Exercise, Heart Failure, Natriuretic Peptide, Brain, Pulmonary Wedge Pressure, Secondary Prevention, Stroke Volume, Thromboembolism, Vascular Diseases, Ventricular Dysfunction, Left
< Back to Listings
