Personalised and unified longitudinal surveillance in cardio-oncology (PULSO): design of a digitally enabled multidisciplinary observational study

Abstract

Cardiovascular (CV) toxicity from cancer therapies is a major cause of morbi-mortality among patients receiving oncologic treatment. ESC cardio-oncology guidelines recommend structured, risk-stratified CV surveillance, yet real-world implementation is inconsistent due to fragmented multidisciplinary pathways and limited-service capacity.

To assess whether implementing a digitally enabled, multidisciplinary best-practice framework increases guideline adherence and standardizes timely CV surveillance and key care processes for patients at risk of treatment-related CV toxicity.

PULSO is a prospective observational pre–post study within the GRACE consortium, supported by the Innovative Health Initiative Joint Undertaking under Horizon Europe. The target population includes adults with breast or lung cancer receiving potentially cardiotoxic therapies. The retrospective cohort will include patients treated between September 2022 and December 2025. Eligibility will be identified from oncology treatment and referrals from cardio-oncology clinic records, enabling calculation of referral coverage for high/very-high CV risk patients. The prospective cohort will enroll patients managed under the optimized digital pathway, with recruitment planned from Q3/2026.

The intervention is a structured shared-care pathway integrating responsible digital monitoring, early alert detection, automated reminders, patient education and coordinated multidisciplinary management. Prospective participants will be followed for 12 months after inclusion or for one year after completion of anticancer therapy, whichever occurs later.

Co-primary endpoints are 1) referral coverage, defined as the proportion of eligible high/very-high risk patients referred to the cardio-oncology clinic and 2) overall adherence to the ESC cardio-oncology guidelines for baseline and end treatment assessment, comparing pre-vs post-implementation cohorts. Secondary endpoints include comparison of overall adherence scores, timeliness of follow-up, adherence across individual guideline domains, digital implementation fidelity (activation and alert resolution), multidisciplinary coordination metrics. Clinical effectiveness and safety outcomes such as incidence of severe CV toxicity requiring hospitalization, cancer treatment interruptions or time between CV toxicity incidence and clinical intervention will also be assessed. To evaluate the best-practice framework, patient and provider-reported outcomes will be analysed. Furthermore, adoption rates of the digital system, implementation and outcomes across demographic subgroups, cost-consequence and cost-effectiveness analysis as well as subgroup analysis by cancer type and treatment will be performed.

PULSO will evaluate a scalable, digitally enabled cardio-oncology pathway designed to improve guideline implementation and strengthen quality and safety in routine care.Figure 1.PULSO study workflow