Although heart failure prognosis is grim, the ALT-FLOW trial’s two year results suggest that diverting blood from the left atrium to the coronary sinus using a shunt could have lasting benefits for patients with HFmrEF/HFpEF.
- There’s no cure for HF, so most treatments focus on extending lifespan and improving quality-of-life by reducing symptoms.
- Current treatments focus on improving blood flow, lowering blood pressure, and relieving kidney fluid pressure, while procedures like CABG or ICD and VAD implantation help avoid HF complications.
Taking a different approach to HF therapy, researchers gave 95 patients the Edwards APTURE Transcatheter Shunt System and found that it improved HF symptoms, quality-of-life, and functional capacity after 2 years.
- Starting off, most patients had NYHA class III symptoms (92.6%) and over a third had been previously hospitalized for HF (37.9%).
- By year two, this improved to 85.5% of patients experiencing class I or II symptoms.
- Shunt implantation also led to improved KCCQ scores, up from a mean of 38.1 points at baseline to 69.8 by year two.
- The APTURE shunt also led to functional improvement, with the 6-minute mean walk distance increasing from 247.5m at baseline to 307.2m by year two.
That’s a pretty impressive two-year improvement – and the cherry on top? APTURE didn’t lead to the adverse effects on right heart structure or function that were common in other HF shunt trials.
However, the study isn’t perfect due to its single-arm design, which means it’s unclear how these benefits would stack up against a control group.
- Sham-controlled studies for other HF shunts have not shown significant improvements in prognosis or symptoms.
- We’ll get more definitive answers from APTURE’s ongoing ALT-FLOW II randomized controlled trial for hemodynamic changes in symptomatic HF patients with stable GDMT.
The Takeaway
While the APTURE system has more to prove, this early feasibility study suggests that the shunt has potential to become an important HF therapy if follow-up trials confirm these results are more than just a happy coincidence.
