Clinical ResearchNo-Implant Interatrial Shunt for HFpEF: 6-Month Outcomes From Multicenter Pilot Feasibility Studies
Central Illustration
Section snippets
Study design
ALLEVIATE-HF-1 and ALLEVIATE-HF-2 were prospective, open-label, uncontrolled, nonrandomized studies. For ALLEVIATE-HF-1, patients were recruited at the Tbilisi Heart and Vascular Clinic (Tbilisi, Republic of Georgia). For ALLEVIATE-HF-2, patients were recruited at Dunedin Public Hospital (Dunedin, New Zealand), Monash Medical Centre (Clayton, Victoria, Australia), Flinders Medical Centre (Bedford Park, South Australia, Australia), and Centre hospitalier de l'Université de Montréal (Montreal,
Population sample and baseline characteristics
Between August 2020 and March 2022, a total of 28 patients were enrolled in the studies. Their mean age was 68 ± 9 years. A majority of the patients were female (n = 19 [68%]). Mean baseline left ventricular ejection fraction was 60.8% ± 8.4%, and body mass index was 36.1 ± 7.5 kg/m2. Enrolled patients were in NYHA functional class III (n = 20) and class II (n = 8). Mean 6MWT was 252 ± 67 meters, indicating impaired functional capacity. Baseline resting and peak exercise PCWP were 19 ± 7 mm Hg
Discussion
The ALLEVIATE-HF-1 and ALLEVIATE-HF-2 studies were first-in-human clinical studies conducted to evaluate the use of a no-implant approach to creating a sustained interatrial shunt. The results of these studies showed procedural success in all patients, with successful excision of atrial tissue and consistent creation of a 7-mm-diameter interatrial shunt with left-to-right shunt flow. All shunts maintained patency at 6 months with no change in size or in ratio of pulmonary to systemic blood
Conclusions
The ALLEVIATE-HF-1 and ALLEVIATE-HF-2 pilot feasibility studies collectively show initial signals of safety and efficacy of the no-implant approach to creating an interatrial shunt. At the 6-month follow-up visit, all patients had patent shunts that remained stable in size. In addition, there was a significant reduction in PCWP from baseline to 1 month, with promising clinical efficacy signals and no serious adverse events through 6 months. Although further validation is needed, these results
Funding Support and Author Disclosures
These studies were funded by Alleviant Medical. Dr Udelson has received consulting fees from Alleviant Medical, Merck, Cardurion, Reprieve CV, Medtrace, and GE. Dr Barker has received consulting fees from and is an advisory board/board member to Alleviant Medical. Dr Gooley has received consulting fees from Boston Scientific, Medtronic, and Abbott Vascular; and is an advisory board member to Boston Scientific and Medtronic. Dr Potter has received research funding and consulting fees from
Acknowledgment
The authors thank Jake Rosen for contributing an early draft of the manuscript.
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