Artificial heart helps 3 PH patients become eligible for heart transplant
Device led to improvements in functional capacity, PH indicators
Implantation of the Aeson Total Artificial Heart — a device from Carmat designed to mimic the heart’s function — was able to help three advanced heart failure patients with pulmonary hypertension (PH) to become eligible for a heart transplant.
The patients, who had previously been considered transplant-ineligible due to underlying PH, experienced reductions in PH severity that made them able to receive their new hearts.
“This publication … highlights the potential of Aeson to safely bridge patients with pulmonary hypertension to a heart transplant,” Piet Jansen, MD, PhD, chief medical officer of Carmat, said in a company press release. “Although larger studies are needed to confirm these findings and establish standardized protocols for pulmonary hypertension management with Aeson, our device represents an important advancement … and a real hope for thousands of patients with this challenging condition.”
The Carmat-funded study, “Precise Monitoring of Transpulmonic Resistance in Bridge to Transplant Patients Supported by The Aeson Total Artificial Heart,” was published in The Journal of Heart and Lung Transplantation. Two of the study authors work for Carmat.
People with advanced heart failure at risk for PH
Up to a quarter of people with advanced heart failure have PH, a condition characterized by elevated pressure in the vessels that supply blood from the heart to the lungs, or the pulmonary arteries.
Heart failure patients with PH are often not considered good candidates for heart transplant, because underlying PH can also cause the right side of the new heart to fail.
Left ventricular assist devices (LVAD) help the left side of the heart pump blood out to the rest of the body. They can be used to ease signs of PH, but their prolonged use has certain limitations, including an increased risk of right-sided heart failure.
The Aeson artificial heart is designed to overcome these limitations and fully replace the function of a failing heart, both its left and right sides, for patients who aren’t eligible for transplant or who are waiting to receive one. It essentially tries to mimic what the heart naturally does, and adjusts blood flow based on the body’s circulation needs.
“Unlike LVADs, which can exacerbate right-sided heart stress, the TAH [total artificial heart] evenly distributes workload across both sides of the heart,” the researchers wrote.
The device is also equipped with sensors that enable real-time estimates of pressure in the heart ventricles, which its developers believe is especially useful for monitoring patients with PH and making informed decisions about when such patients might be eligible for a heart transplant.
Aeson is implanted into the chest and is controlled by an external power supply worn outside the body.
100 people have so far been successfully implanted with Aeson device
The device is commercially available as a bridge to heart transplant for certain people with end-stage heart failure in the European Union, and is currently being assessed in feasibility studies in the U.S., according to Carmat. The company announced recently that 100 people have so far been successfully implanted with the artificial heart.
In the recent publication, scientists reported outcomes from three advanced heart failure patients with PH who were implanted with the Aeson device at the University Medical Center of Astana, in Kazakhstan.
The patients, who were considered ineligible for a heart transplant, received the implant at ages 60, 35, and 54 years.
No major complications occurred after the surgery. Two patients were discharged from the hospital 48 days after the implant (about 1.5 months), and the other was discharged after 68 days (a little over two months).
All three patients exhibited improvements in functional capacity and estimates of pulmonary pressure were reduced within a month for all patients, making all of them become eligible for a heart transplant.
The three patients received their heart transplants 109 days (about 3.5 months), 155 days (about five months), and 243 days (about eight months) after the Aeson implant.
“The Aeson total artificial heart provided autoregulated blood flow to optimize patients’ condition,” said Yuriy Pya, MD, cardiac surgeon at the University Medical Center of Astana and the study’s first author. “Moreover, the non-invasive monitoring of pulmonary resistance … has helped us to determine the best timing for a successful heart transplant in all cases.”
None of the patients experienced right-sided failure of the donor heart. One patient died about 3.5 months after their transplant due to pneumonia and multi-organ failure, while the other two patients remained well as of a two-year follow-up.
“As the demand for heart transplantation continues to grow, the Aeson TAH represents an important advancement … offering new hope for patients with PH and other challenging conditions,” the researchers concluded.
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