Tailoring new treatments with implanted technologies
Pulmonary arterial hypertension (PAH) is a serious and rare disease that can lead to heart failure and premature death. PAH results from a remodelling of blood vessels, leading to increased resistance in the pulmonary arterioles. Based on mainly European data, around 48–55 cases/million people are living with PAH in developed countries, and in the US alone, there are 500-100 new cases diagnosed each year.
Existing therapies mediate pulmonary vascular vasodilatation by acting on different biological pathways. As PAH becomes more severe, the treatment currently relies on more vasodilator drugs. The response to therapy is measured through exercise evaluation and by inserting a catheter in the right side of the heart to measure blood pressure and flow. This invasive procedure dramatically limits the development of new PAH drugs and makes it challenging to tailor treatment to each patient.
The MRI and implantable medical devices alternative
Magnetic resonance imaging (MRI) could be a suitable, noninvasive option for evaluating new PAH drugs. Recent studies showed that MRI can precisely analyse how efficiently the right side of the heart pumps blood and the amount of blood pumped out of the right side with each beat (or right ventricular stroke volume—RVSV). Additionally, implantable medical devices could help evaluate clinical efficacy earlier through continuous remote monitoring.
What you should know about the upcoming study
The paper details a crossover study that aims to enrol 40 patients with PAH to compare the effects of two standard therapeutic treatments. Differences between treatments will be measured using MRI and remote monitoring devices, including a pulmonary artery pressure (PAP) monitor and a minimally invasive cardiac monitor. Following implantation of these devices, patients will receive in random order either 1) an endothelin receptor antagonist combined with a soluble guanylate‐cyclase stimulator (riociguat) or 2) a phosphodiesterase type‐5 inhibitor combined with an endothelin receptor antagonist, and a prostacyclin receptor agonist (selexipag). Twelve-week treatment periods will be followed by a break to fully eliminate the previous treatment. The study will evaluate the impact of different treatments on each patient and determine if remote monitoring devices can be used to assess the efficacy of PAH drugs.
Blood flow response to treatment will be measured by RVSV, mean pulmonary artery pressure (mPAP), heart rate, a 6-minute walk test, MRI measurements and other methods.
Not so fast
While a heart monitor can be implanted in a clinical setting, a PAP monitor must be placed during a right heart procedure to allow for remote tracking of heart and lung function. Both devices are associated with specific risks and may cause device-related adverse effects.
Why does it matter?
Minimally invasive technology could offer a clearer picture of how treatment affects patients in everyday life, providing valuable information between regular hospital visits. This approach may also improve study recruitment and retention factors, which are key to strengthening results. Furthermore, remote monitoring should enable the healthcare team to adjust each patient’s treatment for optimal results while minimising side effects.
Take home messages
1. A new crossover study involving PAH patients will compare two treatment strategies to investigate how each therapy affects a person differently.
2. Pulmonary artery pressure and cardiac monitors will determine the efficacy of PAH drugs for each patient, which could lead to more personalised treatment options.
3. Remote heart and lung function monitoring could provide a clearer picture of treatment effects and promote more patient-centric research.
Guest author: Solène Grosdidier, PharmD, PhD
This article was written as part of a series of ‘journal club’ summaries for Scientific Writers Ltd and is based on the following publication.
First Author: Varian F, et al.
Journal: Pulmonary circulation
Date online: 17 March 2024
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