Developments in EVAR: 2005 and Beyond
During the past year, early results of two major randomized studies comparing EVAR to open repair—EVAR-1 and DREAM—have been published. Both studies have proven without a doubt that EVAR is safer, at least in the short-term than open surgery. This is something we all expected, but it is nice to have Level 1 evidence to support our belief. In 2003, we saw the exit of the Ancure and the introduction of the Excluder and the Zenith grafts, both of which are rapidly catching up in terms of market share with the leader, AneuRx. In this regard, 2004 was a quiet year because we maintained all of the current endografts and the only new device to be introduced was the Endologix Powerlink. However, on the thoracic side, there was a big move. The W. L. Gore TAG device has been recommended for approval with conditions by the FDA. This could result in the first FDA approval of a thoracic endograft and will definitely have a major impact on how we treat patients with thoracic aortic pathology. Other great news for this market includes the fact that the US Preventive Services Task Force issued a report recommending one-time ultrasound screening for AAAs in men age 65 to 75 years who have ever smoked. This legislation is expected to pass Congress sometime in 2006. It has been estimated that there are 1.7 million AAAs in the US, with only 20% being diagnosed and only 3% being treated. With the approval of this screening program, we estimate that the number of AAA surgeries will increase by a factor of 2 to 3. This number may further increase if The Cleveland Clinic/Medtronic-sponsored small AAA stenting trial (PIVOTAL) proves to be positive. Other exciting events to keep an eye on this year include the presentation of the 1-year follow-up results of the EVAR-1 trial, as well as the pivotal trial for the percutaneous TriVascular Enovus endograft and the Vascutek Anaconda trial. Also, we will report on the results of the CardioMEMS wireless pressure sensor trial (APEX) that has recently been concluded.
In this issue of Endovascular Today, Jan D. Blankensteijn, MD, evaluates the data, impact, and issues surrounding the two landmark randomized trials, the EVAR-1 and the DREAM trial. Kenneth Ouriel, MD, provides us with an overview of studies on treating small AAAs. On the other end of that spectrum, however, are the emerging technologies and techniques involving fenestrated devices for treating complex aneurysms. Roy K. Greenberg, MD, shares with us some of the most recent developments and discusses the techniques that interventionists must become familiar with in order to utilize these devices. Another issue of paramount importance is the need for expansive screening programs. John D. Martin, MD, and colleagues have submitted their early experiences with a driven and successful screening and community education program called Dare to C.A.R.E. Also, Carlo A. Dall’Olmo, MD, for the Epics 1 investigators, evaluates AAA screening data from a group of patients with a history of coronary artery bypass grafting, and the Community Wellness Program and the SAAAVE programs are presented. The SVS/AVA Outcomes Registry Steering Committee updates us on the Lifeline Registry and their efforts to evaluate the long-term safety and efficacy of endovascular grafts.
We also report on a recent interventional market analysis that provides insight into the trends that will affect endovascular care in the coming years. Jerry J. Svoboda, MD, presents an interesting method of smoking cessation that you can share with your patients. Finally, we have a great interview with my good friend and colleague, Michael R. Jaff, DO, who is arguably one of the most knowledgeable and insightful individuals in this field.
We hope you find this issue of Endovascular Today to be insightful and informative.