PAPA-ARTIS

Paraplegia Prevention in Aortic Aneurysm Repair by Thoracoabdominal Staging with ‘Minimally- Invasive Segmental Artery Coil-Embolization’: A Randomized Controlled Multicentre Trial

Abstract

Chronic aortic aneurysms are permanent and localized dilations of the aorta that remain asymptomatic for long periods of time but continue to increase in diameter before they eventually rupture. Left untreated, the patients’ prognosis is dismal, since the internal bleeding of the rupture brings about sudden death. Although successful treatment cures the disease, the risky procedures can result in paraplegia from spinal cord ischaemia or even death, particularly for aneurysms extending from the thoracic to the abdominal aorta and thus involving many segmental arteries to the spinal cord, i.e. thoracoabdominal aortic aneurysms of Crawford type II. Although various strategies have achieved a remarkable decrease in the incidence of paraplegia, it is still no less than 10 to 20%. However, it has been found that the deliberate occlusion of the segmental arteries to the paraspinous collateral network finally supplying the spinal cord does not increase rates of permanent paraplegia. A therapeutic option, ‘minimally invasive segmental artery coil embolization’ has been devised which proceeds in a ‘staged’ way to occlude groups of arteries under highly controlled conditions after which time must be allowed for arteriogenesis to build a robust collateral blood supply. PAPA-ARTiS is a phase II trial to demonstrate that a staged treatment approach can reduce paraplegia and mortality dramatically. It can be expected to have both a dramatic impact on the individual patient's quality of life if saved from a wheelchair, and also upon financial systems through savings in; 1) lower costs in EU health care; 2) lower pay-outs in disability insurance (est. at 500k in Year 1), and; 3) loss of economic output from unemployment. Approx. 2500 patients a year in Europe undergo these high risk operations with a cumulative paraplegia rate of over 15%; therefore >100M per year in costs can be avoided and significantly more considering the expected elimination of type II endoleaks.

Project details

Unibo Team Leader: Davide Pacini

Unibo involved Department/s:
Dipartimento di Medicina Specialistica, Diagnostica e Sperimentale

Coordinator:
Universität Leipzig(Germany)

Other Participants:
Insel Gruppe AG (Switzerland)
Warszawski Uniwersytet Medyczny (Poland)
Skane Lans Landsting (Sweden)
Baylor Collage of Medicine (United States of America)
Ecrin-European Clinical Research Infrastructure Network (France)
Ludwig-Maximilians-Universitat Munchen (Lmu) (Germany)
The University Of Pennsylvania (United States of America)
Orebro Lans Landsting (Sweden)
Kite Innovation (Europe) Limited (United Kingdom)
Universite Nord De France Universite Droit Et Sante De Lille 2 Institut Pasteur De Lille (France)
Societe Europeenne De Cardiologie-European Society Of Cardiology (France)
Universitaetsklinikum Hamburg-Eppendorf (Germany)
Academisch Ziekenhuis Maastricht (Netherlands)
SLASKIE CENTRUM CHOROB SERCA W ZABRZU-Silesian Center for Heart Diseases in Zabrze (Poland)
Liverpool Heart And Chest Hospital Nhs Foundation Trust (United Kingdom)
Region Hovedstaden (Denmark)
ALMA MATER STUDIORUM - Università di Bologna (Italy)
Universidad De Granada (Spain)
Universitätsklinikum Freiburg (Germany)
Centre Hospitalier Et Universitaire De Bordeaux (France)
Ospedale San Raffaele S.R.L. (Italy)

Total Eu Contribution: Euro (EUR) 5.913.922,50
Project Duration in months: 60
Start Date: 01/01/2017
End Date: 31/12/2021

Cordis webpage

Good health and well-being This project contributes to the achievement of the Sustainable Development Goals of the UN 2030 Agenda.

UE flag This project has received funding from the European Union's Horizon 2020 research and innovation programme under grant agreement No 733203