Abstract 13527: The Development of a Remote Pulmonary Arterial Hypertension Risk Score Utilising Remote Monitoring Technology to Monitor Parameters Associated With Mortality in Pulmonary Arterial Hypertension

Abstract

Background: In patients with pulmonary arterial hypertension (PAH) risk stratification is used to aid clinical decision making and guide treatment categorising patients as low (<5%), intermediate (5-10%), or high mortality risk (>10%) at 1 year based on hospital investigations. Risk stratification based on remote parameters may facilitate early evaluation of clinical efficacy following treatment change or indicate clinical stability/deterioration, thereby permitting early intervention. Methods: Patients with PH were identified from the ASPIRE (6/YH/0352) database 2/2001-6/2019. Random allocation was used to form a derivation (n=3832). Univariate Cox Regression and stepwise forward multivariate analysis were undertaken in the derivation cohort to identify parameters that may be remote monitored that were associated with mortality. Mortality weighted z-scores of age, incremental shuttle walk test (ISWT), heart rate (HR) and total pulmonary resistance (TPR) were summed to give an individual remote risk score value. LOESS regression was used to determine 1 year risk thresholds applied to a PAH validation cohort (n=590). Results: Multivariate analysis of the derivation cohort demonstrated that ISWT, HR and TPR had statistically significant relationships to mortality. Survival analysis showed increased mortality with each decile of baseline risk score with the 10 th decile at increased risk of mortality compared the 1 st decile (OR 5.5, 95%CI 4.3-7.0, each decile p<0.01, Figure). In patients with PAH, LOESS derived thresholds identified patients at low, intermediate and high risk with 1 year mortalities of 4.6, 9.8 and 15.1% respectively (low-int OR 1.9, low-high OR 2.7,p<0.01,Figure). Conclusion: A score of remote monitored parameters, when applied at diagnosis, accurately categorised patients as low, intermediate, or high risk. This system may be applied to remote monitored physiological data to provide real time risk stratification.

Pulmonary Hypertension: Intensification and Personalization of Combination Rx (PHoenix): A phase IV randomized trial for the evaluation of dose‐response and clinical efficacy of riociguat and selexipag using implanted technologies

“…This study will offer the potential to build on existing evidence showing that remotely monitored parameters may be used at diagnosis to categorize patients with PAH as low, intermediate, or high risk. 24 In addition to offering the potential for early evaluation of therapies, the use of remotely monitored outcomes may provide a broader picture of the effects of treatment on patients' daily functioning. 25 Remote patient monitoring may also facilitate more patientcentric research, and improve study recruitment and retention, which are key issues for research into a rare disease such as PAH.…”

“…9,[19][20][21][22] In patients with PAH, cardiopulmonary hemodynamics are closely associated with clinical outcomes, 7 and are affected by both diseases worsening and increase or withdrawal of therapy. 23,24 The development of minimally invasive technology that provides remote, daily measurement of cardiopulmonary hemodynamic parameters and physical activity may provide more comprehensive coverage of the effects of treatment on patients' daily functioning, allowing insight into the intervening periods between scheduled hospital visits. 25 Remote monitoring may provide benefits to both patients and care teams by allowing remote monitoring of efficacy following a treatment change.…”

Pulmonary Hypertension: Intensification and Personalisation of Combination Rx (PHoenix): A phase IV randomised trial for the evaluation of dose-response and clinical efficacy of riociguat and selexipag using implanted technologies

“…This study will offer the potential to build on existing evidence showing that remotely monitored parameters may be used at diagnosis to categorise patients with PAH as low, intermediate, or high risk. 24 In addition to offering the potential for early evaluation of therapies, the use of remotely monitored outcomes may provide a broader picture of the effects of treatment on patients' daily functioning. 25 Remote patient monitoring may also facilitate more patient-centric research, and improve study recruitment and retention, which are key issues for research into All rights reserved.…”

“…preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in The copyright holder for this this version posted August 24, 2023. ; https://doi.org/10.1101/2023.08. 24.23294547 doi: medRxiv preprint PHoenix and exercise tests to look at exercise ability. Each patient will be in the study for a total of 6 months, following which ongoing treatment choice will be decided at the discretion of the clinical care team.…”

“…10,[19][20][21][22] In patients with PAH, cardiopulmonary haemodynamics are closely associated with clinical outcomes, 8 and are affected by both disease worsening and increase or withdrawal of therapy. 23,24 The development of minimally invasive technology that provides remote, daily measurement of cardiopulmonary haemodynamic parameters and physical activity may provide more comprehensive coverage of the effects of treatment on patients' daily functioning, allowing insight into the intervening periods between scheduled hospital visits. 25 Remote monitoring may provide benefit to both patients and care teams by allowing remote monitoring of efficacy following a treatment change.…”