Matthew Mace (formerly of Abbott and a CardioMEMS expert) sat down with Göran Rådegran in December to review the last two years of development and clinical trials with Acorai. They spoke about what the Acorai Heart Monitor may deliver for patients following the upcoming global trials.
About Göran Rådegran
Göran is a Consultant Cardiologist, Head of the Hemodynamic Lab & PAH ward in Lund at Skane University Hospital, and Associate Professor at Dept. of Clinical Sciences, Cardiology, at Lund University, as well as a steering committee member of the Swedish PAH register (SPAHR) and the Nordic PH Vision group. With over 120 publications on heart failure or pulmonary hypertension, Göran is co-author of the ISHLT consensus statement for managing Pulmonary hypertension (PAH), Head of the Swedish Society of Pulmonary Hypertension, and task force member for the European 2022 PH guidelines.
How important are hemodynamics?
Göran explained that hemodynamics are “critical in deciding what therapy to give patients.”, and there are many technical reasons why traditionally only a Right Heart Catheterization could deliver those insights. In his area of focus, knowing the true hemodynamics can be the difference between a “costly, ineffective treatment, [and] a highly effective one that keeps people out of the hospital” hence managing healthcare resources efficiently. In an ideal world, a right heart catheterization is not a one-time measurement, and the pulmonary hypertension patients who attend Göran’s lab benefit from the skill and expertise of his team with annual repeat right heart catheterizations if clinically needed.
It is clear that “Repeated measurements are essential for monitoring”; for example, with severe heart failure patients, it is used to “track the progress of the patient and the response to therapy”, ensuring that they are on the optimal dose of the four foundational therapies (Guideline Directed Medical Therapy GDMT) and physicians know when to escalate for advanced treatments. For other diseases, such as pulmonary hypertension, the condition is “defined in guidelines by the measurement obtained in the catheterization lab”.
What is the added value of Acorai?
For Göran and the patient who attends SUS, there is a track record of “no severe complications or fatalities related to right heart catheterization,” which is due to the team’s experience and specialism. However, globally the availability of right heart catheterization and the expertise to safely perform the exam may not be readily available. As a result, the number of right heart catheterizations routinely performed is lower than in specialist centers such as SUS, and the reported global complication rate is 1-2%.
Thus, the added value of Acorai will be to “provide non-specialists insights that may help with treatment decisions, initiation of costly drug therapy, or timely referral to a specialist center for advanced therapy.” Göran added that beyond basic hemodynamics, it potentially could be used to “risk stratify patients and provide a definitive mortality risk alongside functional assessment.”
What makes Acorai interesting for a specialist?
The Acorai Heart Monitor can help “map the stability of patients [and] identify where more can be done to improve patient’s quality of life.” If used for early detection, the monitor could be used along with other first-line measurements in all patients with suspected or worsening heart failure for a more accurate assessment.
Clinically it is hard for many specialists and non-specialists to estimate pressure directly with the existing non-invasive tools. “If Acorai could provide validated insights, it could impact risk evaluation [and] easier tracking of response to treatment in a non-hospital or at-home environment.”
Today specialists and hospitals are faced with less capacity of hospital bed spaces for elective procedures and a lower number of skilled, trained healthcare professionals to continue to deliver the best quality of care. Göran proposed that Acorai could help allocate our resources effectively to deliver better patient care. “In short, we have less beds, less nurses, and less time, [and a device that can] inhibit acute admission would be useful.”
Göran’s final word on HF and Acorai
A hospitalization is a sign of treatment failure, and “intervention here is ‘too late’ as patients are in severe disease. We should focus on prohibiting admissions and interventions before it’s ‘too late’”. Today at SUS they use blood testing and an open telephone line to help patients with difficulty, but this requires a nurse to answer the calls and examine the blood results. “These tools are sometimes inaccurate, and other tools like pacemaker devices for remote follow-up are not used routinely as the data may be insufficient to steer medication changes”.
On a horizon of 2-5 years, “I can see Acorai being used as a means of personalized treatment and empowering patients to control their disease more effectively themselves”. All healthcare systems globally need to reduce readmissions, and “hemodynamic monitoring is the only effective way to achieve that and inhibit the acute admission”. With this, “Acorai has made progress, and the technology may further improve.”
A note from Acorai’s CEO Filip Peters
Acorai is honored to be able to work with world-leading experts such as Göran Rådegran and Niklas Berg on the validation of our non-invasive medical device. We are currently expanding our clinical studies to cover more of the world’s population with the help of other fantastic clinical contributors and investigators. The process and results we have seen in our clinical studies are impressive, and I am proud of the fantastic team we have at Acorai that will be able to bring this technology to market, and into the hands of healthcare professionals.
We thank Göran for his time in this interview and for supporting our ongoing clinical investigations, and unrestricted editoral rights were granted to Göran for this interview.