OUTREACH

The successful treatment of congenital heart disease (ConHD) has greatly increased the survival of children with this condition. Many of these defects require surgical or catheter interventions immediately after birth. However, complete restoration of the defect is often unachievable, a high risk of developing heart failure, arrhythmias, sudden cardiac death or blood vessel dilatation or stenosis relatively early in life.

Currently, there is a lack of personalized risk predictors and optimal clinical decision tools, highlighting an unmet need to develop new effective strategies for treating and preventing ventricular failure, arrhythmias, and large vessel diseases.

The Focus
The OUTREACH consortium focuses on specific types of congenital heart diseases (ConHD) related to outflow tract defects, such as transposition of the great arteries, congenital aortic stenosis, and tetralogy of Fallot, which collectively account for over half of all ConHD cases. The goal of OUTREACH is to reduce the risk of mortality and morbidity and improve the quality of life for these patients (both children and adults) by improving follow-up practices based on outcomes, implementing personalized risk assessment tools, and advancing therapeutic strategies.

The Research

The OUTREACH consortium integrates expertise in preclinical research, developmental biology, disease modeling, and clinical research from academic centers specializing in pediatric and adult congenital cardiology and surgery. Its objectives are:

  1. identifying better parameters for risk assessment and early detection of heart failure or ventricular arrhythmias in ConHD patients with outflow tract defects.
  2. Exploring efficient treatments to enhance adaptation and prevent heart failure and vascular damage in at-risk ConHD patients.

This consortium conducts extensive research involving a large cohort of ConHD patients to unravel the underlying causes and mechanisms of cardiac adaptations following surgical interventions. It investigates the molecular mechanisms responsible for outflow tract defects and evaluates whether stimulating heart regeneration in ConHD models can mitigate adverse remodeling and heart failure. Additionally, the consortium explores new non-invasive imaging techniques and blood-derived biomarkers to develop innovative risk analysis tools for clinical decision-making.

  1. In OUTREACH a nationwide registry is created for all patients (children and adults) with ConHD in the Netherlands by harmonizing existing registries KinCor and ConCor. This is an important step towards optimizing the quality of care for the ConHD population and fostering scientific research on ConHD.
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Funded

Contact person:

Prof. W.A. Helbing (Wim)

Principal investigators

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FORSEE

2020
Clinical staff in hospital wards traditionally collect vital signs periodically to assess a patient's cardiorespiratory status, often with intervals of 6 to 10 hours. This method, known as spot-checking, has limitations due to its infrequent nature and dependence on contact sensors, which can be uncomfortable for patients, particularly during sleep. The Focus Recent advancements demonstrate that vital signs like heart rate, respiration rate, blood oxygen saturation, and temperature can be monitored remotely using camera-based methods, which are less invasive compared to contact sensors. This innovation could significantly enhance patient comfort by enabling continuous monitoring without the need for frequent interventions by clinical staff. Continuous monitoring also allows for trend analysis of vital signs, offering a comprehensive assessment of a patient's cardiorespiratory condition. Additionally, camera-based methods enable video context analysis, such as detecting patient movements or identifying pain through facial expression analysis. This project explores the use of continuous video monitoring as an unobtrusive method to predict and monitor patient deterioration or adverse events. The Research Initially, the feasibility and reliability of camera-based continuous monitoring will be evaluated using data from consenting patients in the ICU at Catharina Hospital in Eindhoven and healthy volunteers. Subsequently, robust technologies will be developed to automatically detect signs of patient deterioration by generating automated early warning scores based on measured vital signs. Throughout the project, feedback from clinical staff and patient experiences will inform the design and implementation of camera-based technologies and early warning systems.
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The RACE 9 Observe-AF

2020
Until recently the standard approach of patients with recent-onset atrial fibrillation (AF) involved early cardioversion. In the latest ESC AF guidelines, a delayed cardioversion approach within 48 hours has been added to the recommendations. However, given the self-terminating and recurrent nature of AF, cardioversion may not always be necessary, and rate control medication could suffice to manage symptoms until spontaneous conversion to sinus rhythm occurs. The Focus The RACE 9 Observe-AF trial is a multicenter, prospective, randomized, open-label non-inferiority trial comparing a watchful waiting strategy (intervention) to routine care (control) for patients with recent-onset symptomatic AF. The Research The watchful waiting approach involves symptom reduction through rate control medication and monitoring for four weeks to await possible spontaneous conversion to sinus rhythm. Routine care consists of either early or delayed cardioversion within 48 hours. The primary endpoint of this non-inferiority study is the presence of sinus rhythm on the ECG after four weeks. Several stakeholders and potential end-users are closely involved in defining the study deliverables. An end-user expert committee has been established, consisting of seven patients with a history of arrhythmias, a psychiatrist, a privacy and legal advisor, a cardiologist, an AF nurse, a general practitioner, and two experts in hospital technology implementation. This committee was involved in piloting the device-based rate and rhythm infrastructure, providing feedback for optimization before the study commencement. Additionally, the committee meets regularly to advise investigators on implementing the device-based infrastructure into daily clinical practice post-study. The study will be conducted across multiple centers in the Netherlands, including UMC Groningen, Radboud UMC, Amsterdam UMC, Alrijne Hospital, VieCuri Medical Centre, Zuyderland Medical Centre, Elisabeth-TweeSteden Hospital, Rijnstate Hospital, Martini Hospital, St. Antonius Hospital, Antonius Hospital, Noordwest Hospitalgroup, Medisch Spectrum Twente, and Maastricht University Medical Center.
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