The EUROpean Collaborators on Stent/graft Techniques for aortic Aneurysm Repair (EUROSTAR) Registry programme celebrated its 10th anniversary at this year’s ESVS meeting. Guest speakers, including Mr Peter Harris, Dr Robert Rutherford, Professor Jaap Buth and Professor Jan Blankensteijn, concluded that the Registry had provided the vascular community with many valuable lessons and hailed the Registry as a continuing success story.
The EUROSTAR Registry was established in 1996 to create and maintain a database relating to endovascular procedures for repair of abdominal aortic aneurysms (AAA) undertaken in European vascular centres. The Registry seeks to advance endovascular technology and to assist evidence-based decision making for individual patients and clinicians alike. There are currently over 17,000 patients, in 135 centers, recruited from 18 different European countries contributing to the Registry.
Chairing the meeting, Rutherford, University of Colorado, USA, began by stating that at the time of EUROSTAR’s creation, he was “sceptical as it was a voluntary registry, however, I have come to realise that EUROSTAR has become an important tool in our understanding of endovascular repair of AAA.” He amplified his previous doubts claiming that there would be great difficulty in obtaining information and that the Registry would not be representative of ‘real world’ practice. Moreover, Rutherford said he believed that the Registry would underestimate problems because of a common tendency of participants to under-report them. However, he said that the participation and compliance was better than he believed and that the sheer weight of data had overcome many of the problems associated with incomplete data submissions.
In addition, Rutherford noted that his reservations that important device specific data would not emerge had been largely overcome. Also, he commended the Registry for excluding withdrawn devices as this has prevented it becoming ‘bogged down’ with old data. In fact, data are held on seven different commercially available, CE-approved devices: AneuRx (Medtronic), EVT/Ancure (Guidant Corporation), Excluder (WL Gore & Associates), Vanguard (Boston Scientific Corporation,), Stentor (MinTec Inc), Talent (Medtronic) and Zenith (Cook Incorporated,).
Rutherford concluded that EUROSTAR has documented the significance of AAA outcomes on four key outcome parameters; the impact of excessive oversizing; compared the outcome of different types of endoleaks; showed the effect of improved endograft design; and assessed specific patient aspects such as diabetes, adjuvant outcomes etc.
Next, Harris, Royal Liverpool Hospital, UK, Chairman EUROSTAR Registry, discussed the lessons learnt from the Registry, particularly concerning the design of modern endografts. He commented that EUROSTAR has helped establish that endovascular aneurysm repair (EVAR) is safe, with a low 30-day mortality, however, data from the Registry showed that rupture was the key issue. This was specifically true for first generation devices, said Harris.
In addition, Harris commented that an unacceptably high risk of delayed treatment failure associated with the use of early-generation endografts was recognized quickly and further detailed analysis of the database provided vital information about the modes of failure. Again, this has influenced the evolution of subsequent generations of endografts and clinical applications of EVAR. In particular, the relationship between the diameter of the AAA and the outcome of EVAR. Other outcome events observed during follow-up included endoleaks, migration, severe device kinking, occlusion and aneurysmal growth. Endoleaks were classified into Types I to IV. In comparing old to new stent grafts, Harris said that valuable lessons were learned. For example, new devices incorporate suprarenal hooks, longer bodies, a longer overlap and shorter limbs.
In conclusion, Harris said, “EUROSTAR has provided the building blocks for randomised controlled trials investigating EVAR. It is a tool for quality assurance.”
Following Harris, Buth, Catharina Hospital, Eindhoven, the Netherlands, discussed how EUROSTAR has impacted on current clinical practice. Due to the volume of data available, Buth said EUROSTAR has given researchers two distinct advantages when considering EVAR over open repair; 1) suitability (anatomical); and 2) fitness of patients.
Buth said that overall, according to EUROSTAR, EVAR in selected patients may have a better outcome than a non-interventional policy. Indeed, a realistic gain in life span from EVAR can be expected in high-risk patients with a life expectancy of longer than one-year. Buth said that EVAR outcomes are dependent on age, aneurysm diameter and abdominal access. He concluded, “The clinical impact of EUROSTAR is pretty good.”
Blankensteijn, UMC St Radboud, Nijmegen, the Netherlands, then commented on whether EUROSTAR had confirmed or refuted European randomised EVAR trials results. He said that DREAM and EVAR 1 had demonstrated a short-term advantage for EVAR and that both trials have implications for the need to better define patients who will benefit from EVAR. In addition, Blankensteijn said that the durability data from DREAM and EVAR 1 will be more reliable than EUROSTAR. “That said, EUROSTAR data is comparable with DREAM. The randomised controlled trials are a snapshot, however, the Registry continues to be of significant value,” he concluded.
Finally, Dr Richard McWilliams, Royal Liverpool Hospital, UK, discussed the lessons learned from EUROSTAR already and suggested that continued registration of data will almost certainly be of benefit in the analysis of new endograft technologies for complex thoracic and abdominal aneurysms. He commented that stent graft technologies were undergoing a rapid evolution and highlighted that the emergence of fenestrated and branched stent grafts, could be the beginning of a new horizon for the EUROSTAR Registry.
